[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,56,0,25,[9,50,93,129,158,190,218,256,283,317,344,379,412,442,469,494,518,538,562,584,609,637,675,700,719],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100580982","phase-2-a-study-of-talazoparib-with-or-without-enzalutamide-in-people-with-prostate-cancer-who-have-previously-received-abiraterone-acetate-100580982",false,"NCT06844383","A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate or Darolutamide","A Randomized Open-label Phase 2 Study of TALazoparib With or Without ENzaluTamide in Patients With Metastatic Castration-Resistant Prostate Cancer and HRR Mutations After Progression on Abiraterone Acetate or Darolutamide","TALENT","Inclusion Criteria\n\n• Willing and able to provide, or have a legally authorized representative provide, written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.\n\nNOTE: Privacy authorization may be either included in the informed consent or obtained separately.\n\n* Participants ≥ 18 years of age.\n* Are willing to be randomized into either study arm and adhere to the study protocol.\n* Ability to swallow study capsules and\u002For tablets whole.\n* Are willing to remain on study treatment and to continue undergoing study imaging despite PSA progression unless clinically deteriorating.\n* Histological or cytological proof of predominant adenocarcinoma of the prostate.\n* Presence of a pathogenic homologous recombination repair mutation in at least one of the following genes: BRCA1, BRCA2, ATM (limited to 15% of enrolled participants), CDK12, CHEK2, PALB2, MLH1, NBN, ATR, FANCA, MRE11A, RAD51C. Assessment of HRR mutation status by germline or somatic testing. All testing must be per Clinical Laboratory Improvement Amendments (CLIA)-certified assay and may have occurred at any time prior to or at screening (not required to be completed within the screening window).\n* Metastatic castration-resistant prostate cancer (mCRPC) as demonstrated by one or both of the following:\n\n  * Metastatic disease documented by conventional imaging: computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) chest\u002Fabdomen\u002Fpelvis and bone scan are required to be performed, but metastases do not need to be seen on both modalities. Measurable disease is not required.\n  * Unequivocal prostate-specific membrane antigen (PSMA) positron emission tomography (PET) only defined metastatic disease with negative conventional imaging. PSMA PET imaging is not required to be performed, but may be used to document metastases when relevant.\n* Progressed either via a minimum of 2 rising PSA levels with a minimun of a 1-week interval between each determination or via radiographic progression by any form of imaging while receiving either abiraterone acetate with prednisone for mHSPC or locally advanced disease, OR darolutamide for mHSPC, locally advanced disease, or non-metastatic castration-resistant disease.\n* Progressive disease at start of treatment and in the setting of medical or surgical castration as defined by 1 or more of the following 4 criteria:\n\n  * PSA progression defined as 2 rising PSA levels, above an initial reference value, taken with a minimum of a 1-week interval. If PSA rise is the only indication of progression at start of study treatment, a minimum PSA of 1.0 ng\u002FmL is required and all measured PSA values have to be considered to make a determination of progression.\n  * Soft tissue disease progression as defined by RECIST 1.1.\n  * Bone disease progression defined by PCWG3 with 2 or more new metastatic bone lesions on a whole-body radionuclide bone scan.\n  * Appearance of newly identified, convincingly positive lesion(s) consistent with metastatic prostate cancer on PSMA PET.\n* Surgically or medically castrated, with testosterone levels of \\\u003C50 ng\u002FdL. If the participant is medically castrated, continuous dosing with a gonadotropin-releasing hormone agonist or antagonist must be demonstrated by testosterone level of \\\u003C50 ng\u002FdL and planned to continue throughout study participation.\n* Eastern Cooperative Oncology Group (ECOG) status of ≤2 (Appendix A: Performance Status Criteria).\n* Normal organ function with acceptable initial laboratory values within 35 days of treatment start:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fµl\n  * Hemoglobin ≥ 9g\u002Fdl\n  * Platelet count ≥ 100,000\u002Fµl\n  * Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)\n  * Potassium ≥ 3.5 mmol\u002FL (within institutional normal range)\n  * Bilirubin ≤ 1.3 x ULN (unless documented Gilbert's disease)\n  * Serum glutamic oxaloacetic transaminase\u002Faspartate transaminase (AST) ≤ 2.5 x ULN\n  * Serum glutamic pyruvic transaminase\u002F alanine transaminase (ALT) ≤ 2.5 x ULN\n* Participants must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 4 months after the last dose of study drug. Sperm donation is prohibited during the study and for 4 months after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.\n\nExclusion Criteria\n\n* Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 2 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer or superficial bladder cancer.\n* Prior treatment for metastatic CRPC with an ARPI for ≥ 12 weeks.\n* Prior treatment for non-metastatic CRPC with abiraterone acetate with prednisone, enzalutamide, or apalutamide for ≥ 12 weeks.\n* Participants who received chemotherapy for castration-sensitive prostate cancer are still eligible provided chemotherapy was completed ≥ 28 days prior to start of study treatment.\n* Participants who received PLUVICTO® for castration-sensitive prostate cancer are still eligible provided treatment was completed ≥ 42 days prior to start of study treatment.\n* Use of investigational agents for the treatment of prostate cancer ≤ 28 days of start of study treatment.\n* Prior treatment with a PARP inhibitor.\n* Concurrent treatment with crizotinib.\n* Prior platinum-based chemotherapy for the treatment of prostate cancer.\n* Current or planned use of potent P-gp inhibitors within 7 days prior to randomization. The P-gp inhibitors include: amiodarone, carvedilol, clarithromycin, cobicistat, dronedarone, erythromycin, glecaprevir\u002Fpibrentasvir, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, sofosbuvir\u002Fvelpatasvir\u002Fvoxilaprevir, telaprevir, tipranavir, valspodar, and verapamil.\n* Participants treated within 7 days of randomization with any medication that may result in a drug-drug interaction with study treatment, including strong CYP2C8 inhibitors or inducers; strong or moderate CYP3A4 inducers or substrates of CYP3A4, CYP2C9, or CYP2C19 with a narrow therapeutic index unless considered medically necessary to treat a life-threatening condition. Examples include, but are not limited to, clopidogrel, gemfibrozil, rifampin, carbamazepine, phenobarbital, phenytoin, rifabutin, rifapentine, St. John's Wort, bosentan, efavirenz, etravirine, modafinil, nafcillin, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, warfarin, and S-mephenytoin.\n* Use of hormonal agents with known or potential anti-tumor activity against prostate cancer within 28 days prior to the start of study treatment is prohibited. This includes, but is not limited to, 5-alpha reductase inhibitors, androgens such as testosterone, cyproterone acetate, progestational agents, estrogens, and diethylstilbestrol.\n* Use of herbal products, nutritional supplements, or alternative therapies that may decrease PSA levels within 28 days prior to initiation of study treatment or plans to initiate treatment with these products\u002Falternative therapies during the entire duration of the study. Examples include but are not limited to, saw palmetto, selenium supplements, and grape seed extract.\n* Participants receiving a blood transfusion within 14 days of randomization are not eligible.\n* History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of randomization.\n* Medical conditions such as uncontrolled hypertension as indicated by a resting systolic blood pressure \\> 160 mm Hg or diastolic blood pressure \\> 90 mm Hg at screening, uncontrolled diabetes mellitus, and cardiac disease that would preclude participation, as determined by the investigator.\n* Untreated known or suspected brain metastases or spinal cord compression or clinically significant malignant epidural disease.\n* Use of any prohibited concomitant medications (Appendix C: Medications with the Potential for Drug-Drug Interactions) within 28 days before first dose of study treatment unless otherwise specified as 7 days.\n* Grade \\>2 treatment-related toxicity from prior therapy except alopecia or peripheral neuropathy.\n* Known allergy to any of the compounds under investigation.\n* Any other condition which, in the opinion of the Investigator, would preclude participation in this trial.","MALE","18 Years",{"count":21,"type":22},126,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of this study is to find out whether talazoparib in combination with enzalutamide or talazoparib alone delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have homologous recombination repair (HRR) mutations and have previously received abiraterone acetate or darolutamide",[28,29],"Prostate Cancer (Adenocarcinoma)","mCRPC (Metastatic Castration-resistant Prostate Cancer)",[31,32,33,16,34,35,36],"talazoparib","enzalutamide","PARP inhibitor","androgen receptor signaling inhibitor (ARSI)","Prostate Cancer Clinical Trials Consortium, LLC (PCCTC)","c24-349","RECRUITING","2026-08-19",{"date":40,"type":41},"2026-08-21","ACTUAL",{"date":43,"type":41},"2026-05-04",{"date":45,"type":22},"2030-03",{"name":47,"class":48},"Prostate Cancer Clinical Trials Consortium","OTHER",8,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":82,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100589690","phase-2-proof-of-concept-trial-to-assess-the-efficacy-and-safety-of-fezolinetant-in-improving-vasomotor-symptoms-in-men-with-prostate-cancer-undergoing-androgen-deprivation-therapy-100589690","NCT06957691","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy (Fezo-ADT Trial)","Fezo-ADT","Inclusion Criteria:\n\n* Male sex\n* Age 40 years and older\n* Diagnosis of prostate cancer\n* Androgen deprivation therapy\n* Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week\n* Ability to sign the inform consent\n* Willing to use reliable methods of contraception if partner is of childbearing age\n* Ability to record hot flashes electronically\n\nExclusion Criteria:\n\n* Use of abiraterone acetate\n* Use of docetaxel and other chemotherapeutic agents\n* Liver cirrhosis\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal\n* Total bilirubin above the upper limit of normal\n* Glomerular filtration rate \\\u003C 30 mL\u002Fmin\n* Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics if prescribed for the treatment of hot flashes\n* Use of over-the-counter hormonal agents or herbal compounds\n* Current use of CYP1A2 inhibitors\n* Ingestion of alcohol within 2 weeks prior to the baseline visit\n* Inability to abstain from alcohol use during the study period.","40 Years",{"count":60,"type":22},60,[25],"The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy.\n\nThe main questions it aims to answer are:\n\n* Does fezolinetant improve the frequency and severity of hot flashes?\n* Does fezolinetant cause any harm to the liver?\n* Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters?\n\nResearchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine.\n\nParticipants will:\n\n* Take fezolinetant or a placebo every day for 4 weeks\n* Visit the clinic once every 2 weeks for checkups and tests\n* Keep a diary of the number of times and intensity that they experience hot flashes",[64,28,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],"Prostate Cancer","Prostate Cancer Metastatic Disease","Prostate Cancer Recurrent","Prostate Carcinoma","Prostate Neoplasm","Prostate Adenocarcinoma","Prostate Cancer With Bone Metastasis","Vasomotor Disturbance","Vasomotor Symptoms","Vasomotor Symptoms (VMS)","Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","Vasomotor Symptoms; Hot Flashes","Androgen Deprivation Therapy","Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma","Androgen-deprivation Therapy","Hot Flashes","Hot Flushes","Hot Flushes and\u002For Sweats",[76,79,80,64,72],"2026-08-13",{"date":85,"type":41},"2026-08-17",{"date":87,"type":41},"2026-01-14",{"date":89,"type":22},"2028-12-31",{"name":91,"class":48},"Shehzad Basaria, M.D.",1,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":128},"100650267","phase-2-study-of-oral-mrt-2359-with-apalutamide-in-prostate-cancer-100650267","NCT07745361","Study of Oral MRT-2359 With Apalutamide in Prostate Cancer","MODeFIRe-1 (Molecular Degrader for Inhibitor Resistance): A Phase 2, Open-Label, Multicenter Study of Oral MRT-2359 in Combination With Apalutamide in Patients With Castration-Resistant Prostate Cancer","MODeFIRe-1","Inclusion Criteria:\n\n* Age \\> 18 years\n* A predicted life expectancy of ≥ 3 months and an ECOG performance status ≤ 1\n* Have histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate without small cell histology and with androgen receptor (AR) mutations\n* Have not had prior treatment with more than 1 prior taxane-based chemotherapy regimen for castration-resistant prostate cancer\n* Have no prior treatment with an AR degrader, opevesostat, or similar therapy\n* Has ongoing (chemical or surgical) androgen deprivation with serum testosterone \\\u003C 50 ng\u002FdL (\\\u003C 1.7 nM)\n* Has received prior treatment with poly(ADP-ribose) polymerase (PARP) inhibitor, if appropriate, or deemed ineligible to receive treatment by the Investigator, or has refused PARP inhibitor treatment\n* Has received prior treatment with at least 1 line of ARPi\n* Have disease measurable per Prostate Cancer Working Group 4 (PCWG4) criteria, with or without measurable disease by RECIST 1.1\n* Be able to provide a tumor biopsy for biomarker analysis during the Screening period\n* Have adequate organ function\n\nExclusion Criteria:\n\n* • Have received prior chemotherapy, definitive radiation, or biological cancer therapy within 21 days before the first dose of study treatment or have any AEs that have failed to recover to baseline\n\n  * Have received prior therapy with a GSPT1 degrader that was discontinued due to an AE\n  * Have received prior auto-HCT and have not fully recovered from effects of the last transplant\n  * Have received allogeneic hematopoietic stem cell transplantation within past 6 months and\u002For have symptoms of graft-versus-host disease\n  * Current use of chronic systemic steroid therapy in excess of replacement doses\n  * Have clinically active central nervous system involvement and\u002For carcinomatous meningitis\n  * Have a confirmed history of (noninfectious) pneumonitis that required steroids\n  * Clinically significant cardiac disease",{"count":7,"type":22},[25],"This Phase 2, open-label, multicenter study is conducted in patients with castration-resistant prostate cancer.\n\nPatients in this study receive MRT-2359, an investigational oral medicine, in combination with apalutamide, an oral medicine used to treat prostate cancer. The main purpose of the study is to assess whether this treatment combination can lower prostate-specific antigen (PSA) The study will also evaluate the safety and tolerability of the treatment combination and assess additional measures of anti-tumor activity.",[105,106,64,28],"Castration-Resistant Prostate Cancer (CRPC)","Castration-Resistant Prostate Cancer",[108,109,110,111,112,113,114,115,116,117],"MRT-2359","apalutamide","castration-resistant prostate cancer","CRPC","androgen receptor mutation","AR mutation","PSA response","androgen receptor inhibitor","molecular glue degrader","GSPT1","2026-08-03",{"date":120,"type":41},"2026-08-04",{"date":122,"type":22},"2026-08",{"date":124,"type":22},"2028-04",{"name":126,"class":127},"Monte Rosa Therapeutics, Inc","INDUSTRY",14,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":155,"locationsCount":157},"100577664","phase-1-phase-1-study-of-ace-232-to-treat-patients-with-metastatic-castration-resistant-prostate-cancer-100577664","NCT06801236","Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer","A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC)","Inclusion Criteria:\n\n* Provide written informed consent\n* Metastatic Castration-resistant Prostate Cancer with ongoing androgen - deprivation therapy (ADT) or have bilateral orchiectomy\n* Difficult to treat or intolerant to standard treatment (post at least 1 line of NHA and taxane-based chemo in mHSPC or mCRPC), suitable for investigational treatment;\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Has a life expectancy of at least 6 months\n* Adequate organ function and bone marrow function\n\nExclusion Criteria:\n\n* Receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period;\n* Concomitant use of medications or herbal supplements known to be moderate to strong CYP3A4 inhibitors\u002Finducers, or P-gp inhibitors, known to prolong the QT interval.\n* Any previous treatment-related toxicities have not recovered.\n* Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis.\n* Severe cardiovascular disorders.\n* Known gastrointestinal (GI) disorder or GI procedure\n* History of gastric and duodenal perforation.\n* History of pituitary dysfunction.\n* Poorly controlled diabetes mellitus.\n* Active or uncontrolled autoimmune disease\n* Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis.\n* Other malignancies requiring treatment within 3 years prior to the first dose of study drug\n* Known allergy or hypersensitivity to any of the excipients of ACE-232.\n* Has other medical conditions that at the discretion of the investigator interfere with safety or efficacy evaluation, or treatment compliance.",{"count":137,"type":22},88,[139],"PHASE1","This is an open label, phase I, multi-center study aiming to assess the safety and tolerability in patients with metastatic castration resistant prostate cancer (mCRPC).",[28,29],[143,110,111,144,145,146,147,148,149,150],"ACE-232","Hormone Antagonists","Hormone Substitutes","Antineoplastic Agents","Prostatic Neoplasms","Castration-Resistant","prostate cancer","CYP11A1",{"date":120,"type":41},{"date":153,"type":41},"2025-05-12",{"date":89,"type":22},{"name":156,"class":127},"Acerand Therapeutics (Hong Kong) Limited",9,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":92},"100650421","68ga-psma-11-petmri-for-selecting-men-with-prostate-cancer-for-focal-therapy-100650421","NCT07747493","68Ga-PSMA-11 PET\u002FMRI for Selecting Men With Prostate Cancer for Focal Therapy","The Role of 68Ga-PSMA-11 PSMA PET\u002FMRI in Selecting Patients With Prostate Cancer for Focal Therapy: A Pilot Study","PSMA-FT","Inclusion Criteria:\n\n* Ability to provide written informed consent.\n* Age 18 years or older.\n* Clinically significant prostate cancer (csPCa) with clinical stage ≤ T2c and planned radical prostatectomy.\n* Serum prostate-specific antigen (PSA) ≤ 20 ng\u002FmL.\n* Clinically significant prostate cancer within an MRI-visible lesion, defined as - International Society of Urological Pathology (ISUP) Grade Group 2 or 3 (Gleason score 3+4 or 4+3) in any biopsy core.\n\nExclusion Criteria:\n\n* Inability to lie still for the PET\u002FMRI examination.\n* Known contraindication or hypersensitivity to gallium Ga 68 gozetotide (68Ga-PSMA-11) or to the MRI gadolinium contrast agent, including any component of the formulation.",{"count":49,"type":22},[168],"NA","Focal therapy is a minimally invasive treatment option for some men with localized prostate cancer. Unlike surgery or radiation, focal therapy treats only the area of the prostate containing clinically significant cancer, with the goal of preserving urinary and sexual function. Successful focal therapy depends on accurately identifying all areas of clinically significant prostate cancer before treatment. Currently, multiparametric magnetic resonance imaging (MRI) is the standard imaging method used to determine whether a patient is a suitable candidate for focal therapy. However, MRI may miss some clinically significant cancers, which can lead to incomplete treatment.\n\nThis pilot study will evaluate whether 68Ga-PSMA-11 positron emission tomography\u002Fmagnetic resonance imaging (PET\u002FMRI) can improve the selection of men with localized prostate cancer for focal therapy compared with MRI alone. The study will enroll men with intermediate-risk prostate cancer who are already planning to undergo radical prostatectomy as part of their standard care.\n\nParticipants will receive a single injection of 68Ga-PSMA-11 followed by a PET\u002FMRI scan before surgery. The PET\u002FMRI findings and MRI findings will be reviewed separately and compared with the prostate tissue examined after surgery, which serves as the reference standard for determining the true location and extent of cancer.\n\nThe main question this study is trying to answer is whether 68Ga-PSMA-11 PET\u002FMRI is more accurate than MRI alone in identifying men who are appropriate candidates for focal therapy. The study will also evaluate whether PET\u002FMRI detects more clinically significant prostate cancer lesions than MRI alone.\n\nResearchers hypothesize that 68Ga-PSMA-11 PET\u002FMRI will improve the detection of clinically significant prostate cancer and more accurately identify patients who are suitable candidates for focal therapy, potentially reducing the risk of untreated cancer remaining in the prostate after treatment. If successful, the results of this pilot study will support the development of a larger clinical trial and may help improve future treatment planning for men with localized prostate cancer.",[28,171],"Localized Prostate Cancer",[64,173,174,175,176,171,177,178,179],"Gallium Ga 68 Gozetotide","Positron Emission Tomography Magnetic Resonance Imaging","Multiparametric Magnetic Resonance Imaging","Focal Therapy","Intermediate-Risk Prostate Cancer","Radical Prostatectomy","Diagnostic Imaging","NOT_YET_RECRUITING","2026-07-30",{"date":183,"type":41},"2026-08-05",{"date":185,"type":22},"2026-09-01",{"date":187,"type":22},"2027-12-31",{"name":189,"class":48},"University Health Network, Toronto",{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":92},"100616195","phase-2-redi-caprecovery-of-erectile-dysfunction-induced-in-prostate-cancer-patients-100616195","NCT07302451","REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)","REDI-CaP (Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients). Innovative Management of Patients With Unfavorable Intermediate-Risk Prostate Cancer: a Special Focus on Quality of Life and Erectile Function Recovery","REDI-CaP","Inclusion Criteria:\n\n* Male sex. (This criterion is required for the patient population being studied and for the correct data structuring in CTIS.)\n* Age \\> 18 years;\n* Diagnosis of prostate cancer via transperineal core biopsy;\n* Classified as unfavorable intermediate-risk (T2b-2c, PSA ≤ 20 ng\u002FmL, and Gleason score 7(4+3); ISUP grade 3);\n* Signed informed consent for REDI-CaP protocol;\n* Signed consent for REDI-CaP data processing;\n* Prostate volume ≤ 80 cc;\n* No evidence of prostate capsule invasion (documented by multiparametric MRI of the prostate);\n* Performance status: 0-1;\n* Negative total-body CT with contrast and bone scan for metastases;\n* Negative PSMA PET for secondary lesions;\n* IIEF-5 score: ≥ 8;\n* Patient compliance with completing periodic questionnaires and attending regular follow-ups as required by the study.\n\nExclusion Criteria:\n\n* Have prostate cancer classified as low-risk, favorable intermediate-risk, or high-risk;\n* Exhibit erectile dysfunction at baseline (IIEF-5 score: \\\u003C 8);\n* Show positive PSMA PET results for metastases or pelvic lymph nodes;\n* Have capsular involvement documented by multiparametric prostate MRI;\n* Have contraindications to radiotherapy and\u002For hormone therapy;\n* Are unable to undergo MRI;\n* Cannot adhere to periodic tests and follow-ups;\n* Refuse or have contraindications to the implantation of intraprostatic fiducials.",{"count":199,"type":22},50,[25],"The goal of this study is to evaluate the recovery of erectile function at six months after hormonal therapy cessation in male patients affected by advanced prostate cancer and undergoing radiotherapy. The main questions are:\n\n* How well and how quickly do patients recover their sexual function and overall quality of life after stopping hormone therapy and receiving radiotherapy?\n* How do the details of the radiation treatment (like the dose and how it's delivered) relate to treatment success, side effects, and long-term outcomes such as cancer control, survival, and financial impact? Participants will receive hormonal therapy (Relugolix) following by radiotherapy. They will complete questionnaires on sexual function, quality of life, and financial impact before, during and after treatment, and attend follow-up visits for health assessments. The study will measure how many patients recover erectile function within six months of stopping hormonal therapy, how long recovery takes, how treatment doses relate to outcomes, and assess cancer control, side effects, quality of life, and survival.",[28],[204,205,206,207,208,64],"Erectile Function Recovery","Relugolix","Androgen Deprivation Therapy (ADT)","Stereotactic Body Radiotherapy (SBRT)","Cyberknife System","2026-07-20",{"date":211,"type":41},"2026-07-21",{"date":213,"type":41},"2026-02-23",{"date":215,"type":22},"2031-02-23",{"name":217,"class":48},"National Cancer Institute, Naples",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":230,"conditions":231,"keywords":235,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":92},"100625701","phase-2-pro-boost-lc-whole-gland-boost-strategies-versus-sbrt-monotherapy-in-psma-staged-localized-and-locally-advanced-prostate-cancer-100625701","NCT07426055","PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer","PRO-BOOST-LC: A Prospective, Multi-arm Phase II\u002FIII Clinical Trial Evaluating the Efficacy and Safety of Whole-Gland Boost Using HDR Brachytherapy, LDR Brachytherapy, or Single-Fraction SBRT Following an Ultrahypofractionated EBRT (VMAT) Backbone (5 Gy x 5 Fractions) Compared to Standard SBRT Monotherapy in Patients With Localized and Locally Advanced Prostate Cancer Staged With PSMA PET\u002FCT","PRO-BOOST-LC","Inclusion Criteria:\n\n* Male patients aged ≥18 years.\n* Histologically confirmed adenocarcinoma of the prostate.\n* Localized or locally advanced prostate cancer classified as cT1-4, cN0, cM0.\n* Negative pelvic nodal and distant metastatic disease on baseline PSMA PET.\n* NCCN favourbale or unfavourbale intermediate-, high-, or very high-risk disease.\n* Candidate for definitive radiotherapy with curative intent.\n* ECOG performance status 0-2.\n* Baseline PSA available prior to randomization.\n* Ability to undergo external beam radiotherapy and brachytherapy or SBRT according to protocol.\n* Planned androgen deprivation therapy (ADT) permitted according to protocol-defined risk group.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Evidence of pelvic nodal (cN1) or distant metastatic disease (cM1) on baseline imaging.\n* Prior definitive local treatment for prostate cancer, including prostatectomy, brachytherapy, or definitive external beam radiotherapy.\n* Prior pelvic radiotherapy for any malignancy.\n* Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant ADT.\n* History of other active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer).\n* Contraindications to radiotherapy or anesthesia required for brachytherapy procedures.\n* Severe uncontrolled comorbidities that would preclude protocol treatment.\n* Inability to comply with study procedures or follow-up schedule.",{"count":227,"type":22},1000,[25,229],"PHASE3","PRO-BOOST-LC is a prospective, multicenter, randomized phase II\u002FIII clinical trial for men with localized or locally advanced prostate cancer without lymph node or distant metastases, confirmed using prostate-specific membrane antigen positron emission tomography\u002Fcomputed tomography (PSMA PET\u002FCT).\n\nRadiotherapy is an established curative treatment option for prostate cancer. Several modern radiotherapy strategies can safely deliver high radiation doses to the prostate while limiting dose to surrounding organs. These include stereotactic body radiotherapy (SBRT), high-dose-rate (HDR) brachytherapy, low-dose-rate (LDR) brachytherapy, and combinations of external beam radiotherapy with a prostate boost. However, the optimal dose-escalation strategy for balancing cancer control, treatment-related toxicity, and long-term quality of life remains uncertain in patients staged with modern PSMA PET imaging.\n\nThe aim of PRO-BOOST-LC is to compare definitive SBRT monotherapy with whole-gland prostate boost strategies delivered after a short course of external beam radiotherapy. Participants will be randomly assigned, according to center capability and patient-level technical suitability, to one of the protocol-defined treatment options. The control group receives SBRT monotherapy. The experimental groups receive external beam radiotherapy followed by one of three whole-gland boost techniques: HDR brachytherapy, LDR brachytherapy, or single-fraction SBRT boost.\n\nThe primary objective is to determine whether assignment to a prostate boost strategy improves failure-free survival compared with SBRT monotherapy. Failure-free survival includes biochemical recurrence, local or regional progression, distant metastases, progression-driven salvage treatment, or death from any cause. Key secondary outcomes include metastasis-free survival, overall survival, physician-reported treatment-related toxicity, and patient-reported quality of life, including urinary, bowel, and sexual function.\n\nParticipants will undergo baseline clinical evaluation, PSA testing, prostate MRI, PSMA PET\u002FCT, and quality-of-life assessments. After treatment, participants will be followed regularly with clinical assessments, PSA testing, toxicity evaluation, patient questionnaires, and imaging when clinically indicated. The study is designed to provide long-term evidence on how best to use modern radiotherapy dose escalation for patients with PSMA-staged localized or locally advanced prostate cancer.",[28,232,233,234,171],"Prostate Brachytherapy","Stereotactic Body Radiation Therapy (SBRT)","Dose Escalation: Solid Tumors",[236,237,238,239,240,241,242,243,244,245,246,247],"Radiotherapy","Stereotactic Body Radiotherapy","SBRT","Brachytherapy","High-Dose-Rate Brachytherapy","Low-Dose-Rate Brachytherapy","Dose Escalation","Ultrahypofractionation","PSMA PET","Prostate-Specific Membrane Antigen","Metastasis-Free Survival","Failure-Free Survival","2026-07-18",{"date":211,"type":41},{"date":251,"type":41},"2026-03-19",{"date":253,"type":22},"2035-12",{"name":255,"class":48},"Affidea Nu-med Center of Oncological DIagnostics and Therapy",{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":269,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":282},"100561650","phase-3-docetaxel-to-androgen-receptor-pathway-inhibitors-in-patients-with-metastatic-castration-sensitive-prostate-cancer-and-suboptimal-psa-response-100561650","NCT06592924","Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response","A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response","TRIPLE-SWITCH","Inclusion Criteria:\n\n* Histologically\u002Fcytologically confirmed adenocarcinoma of the prostate or participants with a PSA \\>100 ng\u002Fml (100 ug\u002FL) and radiographic evidence of metastatic disease at diagnosis.\n* Metastatic disease by conventional imaging (bone scan or CT and\u002For MRI or PSMA-PET scan at the time of ADT initiation.\n* PSA of ≥ 2.0 ng\u002Fml (2.0 ug\u002FL) prior to commencement of ADT (this refers to patients who have histologically\u002Fcytologically confirmed adenocarcinoma of the prostate)\n* Patients will have recovered from any treatment-related toxicities prior to enrollment (unless ≤ grade 1, irreversible, or considered by investigator as not clinically significant).\n* Patients may enroll with persistent toxicities attributable to ADT, including hot flushes and fatigue, of any grade, provided these toxicities are clinically stable, not rapidly worsening, and not considered by the Investigator to pose a safety risk or impair the patient's ability to comply with study procedures. Such toxicities do not need to resolve to Grade ≤1 prior to study entry.\n* Receipt of ADT for mCSPC for at least 6 months and no greater than 12 months (+\u002F- 3 weeks) at time of enrollment.\n* Receipt of ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months (+\u002F- 2 weeks) at time of enrollment\n* Patients may have had radiotherapy to prostatic bed and\u002For metastatic sites prior to enrollment. Potential trial participants should have recovered from radiotherapy-related toxicities prior to enrollment.\n* Serum testosterone \\\u003C1.7 nmol\u002FL or 50 ng\u002FdL.\n* PSA ≥ 0.2 ng\u002Fml (0.2 ug\u002FL) within 28 days of enrollment.\n* Candidate for docetaxel chemotherapy\n* ECOG Performance Status (PS) 0 to 2.\n* Adequate organ and marrow function measured within 28 days prior to enrollment.\n* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.\n* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n* In accordance with CCTG policy, protocol treatment is to begin within 10 working days of participant enrollment.\n* If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception\n* HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Participant access to all protocol therapies must be confirmed prior to enrollment\n\nExclusion Criteria:\n\n* Confirmed PSA progression, defined by an increase in PSA of 25% above the nadir since achieving castration on ADT, an absolute increase in PSA value of 2.0 ng\u002Fml (ug\u002FL) above nadir, and a subsequent increase in PSA of 25% further separated by 3 or more weeks.\n* Evidence of confirmed radiographic progression or clinical progression since start of ADT. Participants may be enrolled on the study if, in the opinion of the investigator, any new bone lesions on bone scan and CT represent flare or treatment effect.\n* Docetaxel criteria:\n\n  * Prior treatment with taxane chemotherapy\n  * Grade 2 or worse peripheral neuropathy\n  * Severe hypersensitivity to drugs formulated with polysorbate 80\n* Clinically significant cardiac disease including:\n\n  * History of unstable angina pectoris, symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry.\n  * History of documented congestive heart failure (New York Heart Association functions classification III-IV).\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous.\n* Patients with a prior or concurrent malignancy whose natural history of treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Concurrent treatment with other anti-cancer systemic therapy other than ADT and ARPI.\n* Live attenuated vaccination administered within 30 days prior to enrollment\u002Frandomization.\n* For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* High-grade neuroendocrine prostate cancer or small cell features (except if a participant has no histological diagnosis but a PSA \\>100 ng\u002Fml (\\>100 ug\u002FL) at diagnosis and radiographic evidence of metastatic disease)",{"count":265,"type":22},830,[229],"This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?\n\nThis study would like to find out if this approach is better or worse than the usual approach for prostate cancer.\n\nThe usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).",[28],[270,271],"PR26","Castration sensitive","2026-07-13",{"date":274,"type":41},"2026-07-14",{"date":276,"type":41},"2025-05-28",{"date":278,"type":22},"2031-04-15",{"name":280,"class":281},"Canadian Cancer Trials Group","NETWORK",395,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":290,"sex":291,"minAge":19,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":302,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":92},"100645589","pilot-feasibility-study-of-a-dyadic-culinary-nutrition-intervention-100645589","NCT07702864","Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention","CHEF","Inclusion Criteria: Survivors\n\n* History of prostate cancer diagnosis at any stage (I-IV)\n* Identifies as Hispanic\n* Completed primary curative treatment (e.g., chemotherapy, radiation, surgery) 6 weeks prior to enrollment.\n\nNote: Men on continuing hormone therapy (ADT) or immunotherapy as maintenance or consolidation treatment are eligible. Men on active surveillance only (no treatment) are not eligible.\n\nInclusion Criterion: Caregivers\n\n* Provides unpaid support for the cancer survivor\n* No prior history of cancer (except non-melanoma skin cancer) Note: Caregivers do not need to identify as Hispanic to be eligible\n\nInclusion Criteria: Survivors and Caregivers\n\n* Aged 18-90 years\n* Reports low fruit and vegetable intake\n* Able to write, read, and speak in English or Spanish\n* Access to a mobile device with Internet and a camera\n* Co-residing and able to participate at the same time and location\n\nExclusion Criteria: Survivors and Caregivers\n\n* Cognitive difficulties that preclude answering the survey questions, that answering survey questions or participating in study activities, or providing informed consent.\n* A medical condition, movement or neurological disorder, or medication use that contraindicates participation in meal preparation.\n* Not co-residing (live in the separate households).\n* No survivor or caregiver available or willing to participate simultaneously.\n* Less than 18 years or greater than 90 years of age.",true,"ALL","90 Years",{"count":294,"type":22},40,[168],"This study will determine the feasibility and acceptability of a 12-week dyadic culinary nutrition program among Hispanic prostate cancer survivor\u002Fcaregiver dyads using a randomized controlled trial design.",[298,28,299,300,301],"Neoplams","Cancer Survivors","Caregiver Burden","Nutrition Therapy",[303,304,305,306,307,308],"Cancer survivorship","Caregivers","Hispanic","Men's Health","Nutrition","Pilot study","2026-07-08",{"date":274,"type":41},{"date":312,"type":22},"2027-01-01",{"date":314,"type":22},"2028-04-30",{"name":316,"class":48},"University of Arizona",{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":292,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":343},"100585753","phase-1-a-single-arm-blinded-fluorescent-psma-histopathology-trial-of-as1986ns-100585753","NCT06906471","A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS","Inclusion Criteria:\n\n* suspected prostate cancer warranting standard of care multi-core prostate biopsy\n\nExclusion Criteria:\n\n* Patients receiving same-day therapeutic Lutetium-177 or Actinium-225 PSMA receptor radiation isotope therapy treatment\n* Patients with pre-existing, impaired or abnormal hepatic function, renal function, cardiac function, and abnormal elevated temperature\n* Patients with a creatinine clearance cutoff (CrCl) of \\\u003C 60 mL\u002Fmin",{"count":324,"type":22},10,[139,25],"A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS",[64,28,328],"Fluorescence Imaging",[330,331,332,333,334],"fluorescent agent","PSMA","prostate surface membrane antigen","histopathology","fluorescence-guided surgery",{"date":336,"type":41},"2026-07-09",{"date":338,"type":41},"2026-07-01",{"date":340,"type":22},"2026-12-30",{"name":342,"class":127},"Antelope Surgical Solutions, Inc",2,{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":351,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":355,"conditions":356,"keywords":361,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":92},"100586479","robotic-prostatectomy-artificial-intelligence-low-pressure-pain-ralp-trial-100586479","NCT06915909","Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial","Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial - \"The Monitoring of Patients Outcomes Intraoperatively and Perioperatively Using the Airseal and Stryker Insufflator Undergoing Robotic Assisted Laparoscopic Prostatectomy at a Pressure and Stability of Pneumoperitoneum of 8 mmHg\"","Inclusion Criteria:\n\n* Patient indicated for non-emergent robotic Prostatectomy surgery\n* Patients (or appropriate legal representatives) able to provide written informed consent to participate in the study\n* Males, aged 18 to 75 years\n* Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and\u002For behavioural recommendations and office visits\n* Are American Society of Anaesthesiologists (ASA) Class I, II, or III);\n\nExclusion Criteria:\n\n* Patient participation in a different investigational clinical study within 90 days before screening and for the duration of this trial (unless previously approved by the investigator and Sponsor);\n* Patients requiring any surgical procedure in addition to Prostatectomy and or \u002F Pelvic Lymph node dissection\n* Previous pelvic surgery or previous malabsobtion or restrictive procedures performed for the treatment of obesity\n* Inability to provide informed consent\n* Unable or unwilling to attend follow-up visits and examinations\n* Uncontrolled hypertension (=\u002F\\>Systolic: 180 mmHg\u002FDiastolic: 120 mmHg) and\u002For diabetes mellitus (Blood sugar level: \\>200 mg\u002FdL)\n* Patients who fall into American Society of Anesthesiologists (ASA) Class ≥ IV\n* History of chronic alcohol or drug abuse within 2 years of the screening visit\n* Chronic renal failure or on dialysis\n* Significant complicating medical history or immunocompromised\n* History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma\n* Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;\n* Any medical condition which precludes compliance with the study\n* Subjects with any other clinically significant unstable medical disorder, life threatening disease, or conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and\u002For the soundness of this clinical study or which would contra-indicate a surgical procedure.\n* Previous or current history of being on regular analgesia \u002F pain killers","75 Years",{"count":353,"type":22},100,[168],"The 'Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial' aims to assess the feasibility of being able to review operative outcomes such as pain when comparing two commonly used surgical devices for the removal of prostate cancers. The data collected will inform methodologies for future, larger, multi-center trials investigating pain in patients undergoing prostate cancer surgery.\n\nA robotic prostatectomy is a commonly performed surgery used to treat prostate cancer by removing the prostate gland. In order to perform the procedure, the surgeon must 'inflate' (technical term pneumoperitoneum) the patients abdomen with carbon dioxide gas using a device called an insufflator. Adequate 'inflation' of the abdomen ensures the surgeon can clearly visualise the prostate. Unfortunately, higher pressures of abdominal 'inflation' are a large contributor to intra and post-operative pain in patients having prostatectomies. The type of insufflator device used to maintain inflation pressures in the abdomen are thought to be a variable contributing to differing levels of intra and post-operative pain. Therefore, the purpose of this trial is to compare intra and post-operative pain when using two different insufflator devices when performing robotic prostatectomies. Both insufflators are already commonly used across multiple NHS Trusts.\n\n40 patients awaiting a robotic prostatectomy at the urology department at the Lister hospital, Stevenage, will be randomised to use either the Conventional Insufflator System (CIS) {Stryker PneumoClear Insufflator} or the AIRSEAL® Insufflation System (AIS) to 'inflate' their abdomens during their prostatectomies. Data relating to various intra and post-operative outcomes will be collected in the 30 days following the patient's operation. Outcomes include levels of intra and post-operative pain, medication use, procedure time, recovery room time, length of hospital stay, post operative nausea and vomiting and adverse events. This data can be analysed to identify trends in differences in outcomes between the AIS and CIS insufflators.\n\nAn amendment has been approved to recruit an additional 60 participants, total overall recruitment is 100.",[28,357,358,359,68,360],"Prostate Cancer (Post Prostatectomy)","Prostate Cancer Surgery","Prostate Cancers","Prostatectomy",[149,362,363,364,365,366,367,368,369],"prostatectomy","robotic prostatectomy","post-operative pain","pain","Stryker PneumoClear insufflator","AirSeal Insufflation System","intra-operative pain","Medasense","2026-07-03",{"date":309,"type":41},{"date":373,"type":41},"2025-04-22",{"date":375,"type":22},"2027-08-17",{"name":377,"class":378},"East and North Hertfordshire NHS Trust","OTHER_GOV",{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":389,"phases":4,"briefSummary":390,"conditions":391,"keywords":395,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":411},"100580196","online-adaptive-stereotactic-body-radiotherapy-for-localized-prostate-cancer-100580196","NCT06834152","Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer","Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer in Patients With Lower Urinary Tract Symptoms and\u002For Prostate Hyperplasia (X-SMILE)","X-SMILE","Inclusion Criteria:\n\n* histologically confirmed localized prostate cancer\n* planned treatment is SBRT according to standard of care and consists of definitive CT or MRI online adaptive SBRT of the prostate according to the PACE trial which includes a total dose to clinical target volume 1 (CTV1, i.e. prostate and proximal 1 cm of the seminal vesicle) of 40.0 Gy in 5 weekly fractions (single dose of 8.0 Gy) and total dose to planning target volume 1 (PTV1) of 37.5 Gy in 5 weekly fractions (single dose of 7.5 Gy) with a compromise for bowel sparing allowed. For patients with unfavorable intermediate to very high-risk disease (according to NCCN guidelines) a total dose to the planning target volume 2 (PTV2, i.e. proximal 1-2 cm of the seminal vesicle) of 32.5 Gy in 5 weekly fractions (single dose of 6.5 Gy) will be delivered.\n* intermediate to (very) high risk localized prostate cancer (≤ cT3a and Gleason score ≤ 9 and\u002For PSA ≤ 20 ng\u002Fml)\n* prostate volume \\> 60 cc and\u002For IPSS \\> 12;\n\nExclusion Criteria:\n\n* Very high risk localized prostate cancer with indication for ADT and ARPI (i.e. Gleason ≥ 8 and cT3a)\n* Involvement of seminal vesicles (cT3b)\n* Contraindications against definitive CT or MRI-adaptive radiotherapy of the prostate, e.g. inflammatory bowel disease (IBD); previous radiotherapy in the pelvis, previous local radiotherapy of the prostate, contraindication for MRI or CT;\n* Patients with severe genitourinary symptoms (e.g. recent urinary retention ≥ grade 3 according CTCAE v.5.0);\n* Lymph node metastases or distant metastases (i.e. no localised prostate cancer);\n* Participation in a clinical trial which might influence the results of this project.",{"count":388,"type":22},75,"OBSERVATIONAL","The aim of this phase II international multicenter study is to evaluate the safety, feasibility, and efficacy of CT or MRI-adaptive SBRT, delivered in five weekly fractions, in patients with newly diagnosed localized prostate cancer who have lower urinary tract symptoms and\u002For prostatic hyperplasia.",[392,28,393,394],"Localized Prostate Carcinoma","Prostate Hyperplasia","Lower Urinary Track Symptoms",[396,238,397,398,399,400,401,402,149],"radiotherapy","MRI","CT","stereotactic radiotherapy","localized prostate cancer","lower urinary tract symptoms","prostate hyperplasia",{"date":404,"type":41},"2026-07-06",{"date":406,"type":41},"2024-03-01",{"date":408,"type":22},"2031-06-30",{"name":410,"class":48},"University of Zurich",3,{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":18,"minAge":420,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":23,"phases":424,"briefSummary":425,"conditions":426,"keywords":429,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":411},"100579264","efficacy-of-intraoperative-arista-polysaccharide-application-on-the-postoperative-blood-loss-in-patients-undergoing-rarp-for-the-treatment-of-prostate-cancer-100579264","NCT06822036","EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER","PROSPECTIVE RANDOMIZED CONTROLLED TRIAL EVALUATING THE EFFICACY OF INTRAOPERATIVE ARISTA™ AH POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING ROBOTIC ASSISTED RADICAL PROSTATECTOMY FOR THE TREATMENT OF PROSTATE CANCER","ARISTA","Inclusion Criteria:\n\n* Age range ≥ 45 to ≥68 yrs\n* Biopsy proven prostate cancer treated with robotic-assisted radical prostatectomy\n* Intrafascial nerve sparing surgery (unilaterally or bilaterally)\n* Preoperative urinary continence\n* Group A Preoperative unassisted International Index of Erectile function (IIEF)-5 score range 8-16 (i.e. moderate (8-11) and mild to moderate (12-16))\n\nExclusion Criteria:\n\n* Severe intellectual limitations preventing to fully understand the study concept and its content\n* High risk prostate cancer (PSA ≥ 20 ng\u002Fml or biopsy Gleason-Score ≥ 8 or suspected T4)\n* Suspected bone or visceral metastases at preoperative imaging Neoadjuvant androgen deprivation therapy\n* Any prior local therapy of the prostate (including subvesical deobstruction or radiation therapy)\n* Any prior chemotherapy or colon\u002Frectal surgery\n* Any prior pelvic trauma that required surgical intervention\n* Depression or other psychological or neurological disease (dementia, schizophrenia, bipolar disorder etc.)\n* Peyronie's disease\n* Polyneuropathia\n* IPSS Score \\>19 and QoL \\>3\n* Bilateral secondary (complete or partial) resection of the neurovascular bundle\n* No contraindications for phosphodiesterase type 5 inhibitor intake (i.e. suited for most penile rehabilitation regimes)\n* Any endocrine function disorder (not including diabetes)\n\nSURGICAL AND PERIOPERATIVE EXLUSION CRITERIA:\n\n* Accessory pudendal arteries (APA) preservation, if an APA is identified\n* For a) nerve sparing and b) controlling bleeding in the area of the prostate bed and neurovascular bundles after prostate removal, no monopolar thermal application are allowed but suturing and clip application is allowed. For secondary resection of the neurovascular bundle and controlling bleeding, mono- or bipolar thermal application, clip application and suturing is allowed.\n* No surgical revision within 7d after RARP (Clavien Dindo classified complication ≥3b)\n* No definitive anastomotic partial or complete rupture (identified via cystogram within 30d after RARP)","45 Years","68 Years",{"count":423,"type":22},362,[168],"We perform a multicenter randomized controlled prospective study with superiority trial design, in which the polysaccharide ARISTA™ AH hemostat agent is applied to the neurovascular bundle areas after prostate removal, during Robot-assisted radical prostatectomy.\n\nWe examine if such agent leads to a relevant clinical improvement indicated by higher postoperative hemoglobin levels compared to the control group. As an exploratory co-primary endpoint of interest, we examine erectile function after Robot-assisted radical prostatectomy based on IIEF-5 score between groups 3, 6 and 12 months after Robot-assisted radical prostatectomy",[28,427,428],"Blood Loss, Postoperative","Erectile Function",[149,430,431,432],"blood loss","potency rates","ARISTA™ AH","2026-05-27",{"date":435,"type":41},"2026-05-29",{"date":437,"type":41},"2025-01-16",{"date":439,"type":22},"2027-01-30",{"name":441,"class":48},"St. Antonius Hospital Gronau",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":451,"briefSummary":452,"conditions":453,"keywords":454,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":343},"100639912","phase-2-prostate-androgen-response-investigation-using-a-stratification-biomarker-predicting-prostate-cancer-downstaging-by-neoadjuvant-darolutamide-with-pcai-immunoscore-100639912","NCT07617272","Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore","PARIS-BIO - Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore in a Non-randomised Open Label Prospective Trial","PARIS-BIO","Inclusion Criteria:\n\n* Biopsy-confirmed high-risk prostate cancer defined as: Global ISUP score \\> 3 with any MRI PI-RADS score OR Global ISUP score = 3 with MRI PI-RADS score = 5\n* Candidate for radical prostatectomy\n* Clinical prostate MRI not older than 3 months at screening\n* ECOG performance status score of 0 or 1\n* Able to receive Darolutamide for 90-120 days\n* Signed informed consent form\n* Willingness to use contraception if sexually active\n\nExclusion Criteria:\n\n* Metastatic (M1) or node-positive (N2) disease\n* Prior treatment with androgen receptor antagonists\n* Prior treatment with gonadotropin-releasing hormone (GnRH)\n* History of prior systemic or local therapy for prostate cancer (including radiation and focal therapy)\n* Major surgery \\\u003C4 weeks prior to inclusion",{"count":353,"type":22},[25],"The PARIS-BIO study evaluates whether a novel genomic biomarker, the PCAI ImmunoScore, can predict the response to neoadjuvant treatment with Darolutamide in patients with high-risk localized or locally advanced prostate cancer. Patients will receive Darolutamide monotherapy for 90-120 days prior to radical prostatectomy. The study aims to validate if the biomarker can identify patients who achieve Minimal Residual Disease (MRD) at the time of surgery.",[28],[455,456,457,458,459],"Prostate cancer","Neoadjuvant","Darolutamide","ARPI","Prediction of treatment response","2026-05-24",{"date":462,"type":41},"2026-06-01",{"date":464,"type":41},"2025-11-09",{"date":466,"type":22},"2030-12",{"name":468,"class":378},"Region Stockholm",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":478,"briefSummary":479,"conditions":480,"keywords":482,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":490,"leadSponsor":492,"locationsCount":92},"100638317","phase-3-comparative-analysis-of-immunological-responses-to-vitamin-d-replacement-therapy-in-black-and-west-african-men-diagnosed-with-prostate-cancer-elucidating-differential-effects-on-immune-function-between-patients-with-localized-disease-and-those-with-metastatic-progression-100638317","NCT07598032","Comparative Analysis of Immunological Responses to Vitamin D Replacement Therapy in Black and West African Men Diagnosed With Prostate Cancer: Elucidating Differential Effects on Immune Function Between Patients With Localized Disease and Those With Metastatic Progression","iCCaRE","Inclusion Criteria:\n\n* Self-identified Black\u002FWest African Males, Age ≥18 years\n* Patients with a previous history of localized or metastatic or locally recurrent prostate cancer\n* Willing to travel to the University of Ilorin Surgery Outpatient Department (SOPD UITH)for baseline and 8 weeks visit for blood collection, if eligible.\n\nExclusion Criteria:\n\n* Known hypersensitivity to vitamin D.\n* End-stage renal failure on dialysis\n* Liver cirrhosis\n* Currently taking a vitamin D or multivitamin supplement, which has more than 400 IU\u002F10mcg of vitamin D daily for the past month.\n* Legal inability or restricted legal ability, medical or psychological conditions not allowing proper study completion or informed consent signature.\n* History of hypercalcemia",{"count":477,"type":22},200,[229],"This study is testing whether fixing vitamin D deficiency in Black\u002FWest African men with prostate cancer can strengthen their immune system, improve quality of life, and even slow cancer progression compared to those who remain deficient.\n\nKey ideas being tested:\n\n1. More than half of Black\u002FWest African prostate cancer patients don't have enough vitamin D.\n2. Low vitamin D weakens immune cell function and affects quality of life, but these problems improve after 8 weeks of vitamin D supplements.\n3. Immune cell function differs between patients with advanced\u002Frecurrent prostate cancer and those with localized disease.\n4. Patients with advanced disease who show stronger immune responses after vitamin D correction may live longer without their PSA levels rising (a marker of cancer progression).\n5. Immune cell function in Black\u002FWest African patients is different from that in Black\u002FAfrican American patients, and this will be checked by comparing data with a parallel Mayo Clinic study.\n\nOverall goals:\n\n1 . Measure how widespread vitamin D deficiency is in Black\u002FWest African prostate cancer patients.\n\n2\\. Understand how vitamin D levels affect immunity and quality of life. 3. Compare immune function between different groups (localized vs. advanced disease, West African vs. African American patients).\n\n4 . See if vitamin D replacement improves both patient well-being and cancer outcomes.\n\nStudy Flow\n\n1\\. Recruitment \\& Consent: Patients with prostate cancer (localized or advanced) are invited and give written consent.\n\n2 . Initial Blood Test (10 mL): Check vitamin D and calcium levels. 3. Eligibility: If vitamin D is low (\\\u003C30 ng\u002FmL), patients join the treatment phase.\n\n4\\. Baseline Testing (50 mL blood + QOL survey): Immune function measured; quality of life survey completed; virtual doctor consult.\n\n5\\. Treatment (8 weeks): Daily vitamin D3 pills (2000 IU, free); patients keep a medication diary.\n\n6\\. Midpoint Check (Week 4): Phone call to check side effects and compliance. 7 .End of Treatment (Week 8): Repeat blood tests (60 mL), second QOL survey, virtual consult.\n\n8\\. Follow up (up to 3 years). Annual phone calls and medical record review to track progression-free survival.\n\nIn short, the study is trying to show that vitamin D deficiency is common in Black\u002FWest African prostate cancer patients, that it harms immune function and quality of life, and that correcting it could improve both health and cancer survival.",[28,481],"Vitamin D on Tumor Response and Inflammatory Markers",[483,484,485],"Advanced Prostate Cancer","Vitamin D deficency","immunity","2026-05-17",{"date":488,"type":41},"2026-05-20",{"date":462,"type":22},{"date":491,"type":22},"2028-09-01",{"name":493,"class":48},"University of Ilorin Teaching Hospital",{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":291,"minAge":501,"maxAge":292,"enrollmentInfo":502,"targetDuration":4,"studyType":23,"phases":503,"briefSummary":504,"conditions":505,"keywords":506,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":343},"100608048","dyadic-co-learning-intervention-for-patients-with-prostate-cancer-and-their-spouses-100608048","NCT07196488","Dyadic Co-learning Intervention for Patients With Prostate Cancer and Their Spouses","Development and Exploring the Efficacy of a Dyadic Co-learning Intervention for Patients With Prostate Cancer and Their Spouses","Inclusion Criteria:\n\nFor Patients:\n\n1. Diagnosed with prostate cancer by a board-certified urologist.\n2. Has either decided on a treatment plan or completed treatment within the past two years.\n3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nFor Spouses:\n\n1. Must be a cohabiting spouse of the prostate cancer patient and aged 20 years or older.\n2. Must have a Barthel Index score of 91 or above, indicating good functional independence.\n\nExclusion Criteria:\n\nEither the patient or the spouse will be excluded if:\n\n1. Diagnosed with another type of cancer.\n2. Diagnosed with cognitive impairment or a psychiatric disorder, such as dementia, depression, or anxiety.","20 Years",{"count":60,"type":22},[168],"This study aims to help patients with prostate cancer and their spouses cope better with the challenges of cancer by learning and supporting each other together. The investigators will test an 8-week \"Dyadic Co-learning Intervention,\" which includes weekly learning topics, a mobile app, and professional support. The goal is to improve their physical symptoms, emotional well-being, and resilience.\n\nParticipants will be randomly assigned to one of two groups. One group will receive regular care, while the other group will receive regular care plus the new co-learning program. The investigators will ask both patients and their spouses to complete questionnaires at the beginning of the study, and again at 10 and 16 weeks, to understand how the program affects their health and well-being.",[28],[455,507,508],"emotional well-being","physical symptoms","2026-05-16",{"date":511,"type":41},"2026-05-19",{"date":513,"type":41},"2025-10-13",{"date":515,"type":22},"2026-07-31",{"name":517,"class":48},"National Taipei University of Nursing and Health Sciences",{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":4,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":92},"100617289","phase-1-phase-i-study-of-docetaxel-and-177-lutetium-psma-it-in-first-line-treatment-for-patients-with-metastatic-castration-resistant-prostate-adenocarcinoma-100617289","NCT07316686","Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma","Inclusion Criteria:\n\n1. Men aged 18 years or older.\n2. Histological or cytological diagnosis of prostate adenocarcinoma. The presence of intraductal or cribriform carcinoma will be allowed.\n3. Presence of metastatic disease on conventional imaging exams (bone scintigraphy and\u002For CT scan or MRI).\n4. Patients with castration-resistant disease, defined as testosterone \\\u003C50 ng\u002FmL in the context of prior orchiectomy or ongoing androgen deprivation therapy (ADT) with LHRH agonists or antagonists, plus at least one of the criteria below:\n5. PSA ≥2.0 ng\u002FmL with at least two consecutive PSA rises at intervals of at least 1 week.\n6. Radiologic progression defined by the investigator.\n7. Clinical progression defined by the investigator.\n8. Performance status per the Eastern Cooperative Oncology Group (ECOG) equal to 0 or 1.\n9. Willingness to continue ongoing ADT.\n10. Adequate organ function as defined below:\n\n    * Parameter Requirement\n    * Neutrophils ≥ 1,500\u002FµL\n    * Hemoglobin ≥ 12 g\u002FdL\n    * Platelets ≥ 100,000\u002FµL\n    * Creatinine ≤ 1.5 x upper limit of normal\n    * Potassium \\> 3.5 mmol\u002FL and \\\u003C5.0 mmol\u002FL\n    * Total Bilirubin ≤ ULN (unless Gilbert's disease)\n    * AST (TGO) ≤ 2.5 x ULN\n    * ALT (TGP) ≤ 2.5 x ULN\n11. 68Ga-PSMA-PET\u002FCT performed during the screening phase showing metastatic (extraprosthetic and extrapelvic) disease with radiotracer uptake and:\n12. SUVmax ≥20 in at least one site;\n13. SUVmax \\>10 in all other measurable metastatic sites.\n14. Lesions with uptake at least 1.5 times greater than hepatic background will be considered measurable.\n\nExclusion Criteria:\n\n1. Presence of any small-cell or neuroendocrine component of prostate carcinoma.\n2. Prior receipt of chemotherapy or radiopharmaceuticals in the castration-resistant setting.\n3. Presence of another active malignancy requiring treatment or a cancer diagnosis within the past 5 years. Carcinoma in situ of any site, squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or papillary bladder tumors will be allowed if previously treated.\n4. Severe urinary incontinence at the investigator's discretion.\n5. 18F-FDG-PET\u002FCT will be performed during screening and will be considered exclusionary if there is discordance with the 68Ga-PSMA-PET\u002FCT. Discordance is defined as FDG-hypermetabolic lesions with absent or low PSMA uptake (SUVmax \\\u003C10) in more than 50% of measurable metastatic lesions.\n6. Patients with brain metastases visible on 68Ga-PSMA-PET\u002FCT.",{"count":525,"type":22},18,[139],"This is a Phase I, open-label, single-center study evaluating the safety, tolerability, and recommended Phase II dose of docetaxel when combined with a fixed dose of 177-Lutetium-PSMA-I\\&T in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Patients will receive standard androgen deprivation therapy, docetaxel at escalating doses (50 mg\u002Fm², 60 mg\u002Fm², 75 mg\u002Fm² every 3 weeks), and 177Lu-PSMA-I\\&T at a fixed dose of 7.4 GBq every 6 weeks (up to 4 cycles). A 3+3 dose escalation design will be employed. Secondary endpoints include safety profile, treatment-limiting toxicities, treatment completion rate, and delayed toxicity. Exploratory endpoints include PSA response, radiographic progression-free survival (rPFS), and PERCIST-based response rate.",[28],"2026-05-14",{"date":531,"type":41},"2026-05-18",{"date":533,"type":22},"2026-06",{"date":535,"type":22},"2026-12",{"name":537,"class":48},"Instituto do Cancer do Estado de São Paulo",{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":23,"phases":548,"briefSummary":549,"conditions":550,"keywords":551,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":92},"100634609","a-study-to-evaluate-the-performance-of-confocal-microscopy-to-detect-positive-margins-during-radical-prostatectomy-100634609","NCT07541911","A Study to Evaluate the Performance of Confocal Microscopy to Detect Positive Margins During Radical Prostatectomy","A Study to Evaluate the Performance of En-face Fluorescence Confocal Microscopy (LaserSAFE) for Margin Analysis During Radical Prostatectomy","LaserSAFE","Inclusion Criteria:\n\n* Patients diagnosed with clinically significant operable cT2-T3a N0 M0 PC.\n* Medically fit to undergo RARP.\n* Scheduled for robot-assisted RARP with a recommendation against intrafascial nerve sparing on at least 1 side based on multidisciplinary meetings informed by MRI, biopsy result and clinical factors.\n* Ability to read English sufficiently to understand PIS and able to give informed consent.\n\nExclusion Criteria:\n\n* Patients who received neo-adjuvant ADT.\n* MRI informed very low likelihood for extra prostatic extension in the proximity of NVB (Based on EPE Likert 1 score or tumour away from the posterolateral areas of the prostate)\n* MRI informed high likelihood for extra prostatic extension in the proximity of NVB (based on Likert 5 score or bulging tumour on MRI T2 images)\n* Patients in whom preoperative imaging shows rectal involvement or seminal vesicle invasion in which nerve-sparing is deemed not feasible due to oncological safety concerns.\n* Patients who received previous treatment for prostate cancer: External beam radiotherapy, brachytherapy, focal therapy, chemotherapy.",{"count":547,"type":22},693,[168],"The goal of this study is to find out whether a new method called \"LaserSAFE\" can accurately detect cancer at the edge of the prostate (called a positive margin) during prostate surgery. LaserSAFE uses a special microscope in the operating room to quickly scan the prostate after it has been removed from the body. This information can help surgeons decide whether it is safe to preserve the nerves around the prostate. This is especially important for patients who are not usually considered suitable for nerve-sparing surgery using current methods. The study will also assess how quickly and reliably LaserSAFE provides this information during surgery.\n\nThe main questions it aims to answer are:\n\nCan LaserSAFE accurately detect cancer at the edges of the prostate during surgery? Can LaserSAFE help surgeons safely decide whether to preserve or remove the surrounding nerves?\n\nResearchers will evaluate the use of the LaserSAFE technique during surgery to see if it improves decision-making about nerve preservation compared to standard practice.\n\nParticipants will:\n\nComplete a quality of life questionnaire before surgery Undergo standard prostate surgery, where the surgeon will initially try to preserve the nerves Have their removed prostate analysed during surgery using the LaserSAFE technique Have additional tissue removed if LaserSAFE detects cancer at the edges of the prostate Attend routine follow-up visits as part of standard care Complete quality of life questionnaires at 3 and 12 months after surgery",[64,28],[552,360,553,455],"Confocal microscopy","Positive margins","2026-05-13",{"date":531,"type":41},{"date":557,"type":41},"2026-04-20",{"date":559,"type":22},"2031-05-20",{"name":561,"class":48},"University College, London",{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":569,"targetDuration":4,"studyType":389,"phases":4,"briefSummary":570,"conditions":571,"keywords":573,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":343},"100582403","flotufolastat-f-18-pet-in-men-with-very-low-psa-recurrence-100582403","NCT06862856","Flotufolastat F 18 PET in Men With Very Low PSA Recurrence","A Prospective Study of Flotufolastat F 18 Positron Emission Tomography in Men With Very Low Prostate Specific Antigen Recurrence","Inclusion Criteria:\n\n* Participants must have a history of localized histologically confirmed adenocarcinoma of the prostate and have received radical prostatectomy (RP) with curative intent.\n* Participants must have measurable disease, defined as a non-zero PSA value post-RP that is concerning for biochemically recurrent or persistent disease, is ≤0.20 ng\u002FmL, and obtained within 60 days of PET\u002FCT.\n* At least 6 weeks must have elapsed after RP. If previously taking ADT, it should have been discontinued at least 16 weeks prior to PET.\n* Participants with a clinical flotufolastat F 18 PSMA PET\u002FCT scan prescribed as part of the standard of care management.\n* Age ≥18 years.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants currently receiving ADT (defined as surgical orchidectomy; luteinizing hormone-releasing hormone \\[LHRH\\] agonist alone \\[continuous or intermittent\\]; LHRH antagonist alone \\[continuous or intermittent\\]; administration or use of a first or second generation anti-androgen alone or in combination with an LHRH agonist\u002Fantagonist).\n* Participants who are receiving any other investigational agents for this condition within five biological half-lives prior to administration of flotufolastat F 18.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to flotufolastat F 18 or other agents used in study.\n* Participants receiving any of the following substances will be considered ineligible: x-ray contrast agent \\\u003C24 hours prior to the flotufolastat F 18 PET and any other PET imaging agent within 24 hours or 10 half-lives, whichever is longer, prior to the flotufolastat F 18 PET\u002FCT. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.",{"count":199,"type":22},"The purpose of this study is to assess detection rate of flotufolastat F 18 positron emission tomography (PET) for low prostate specific antigen (PSA) recurrence of prostate cancer (PC) following radical prostatectomy.",[28,572],"Prostate Specific Antigen",[574,575,149],"flotufolastat F 18 positron emission tomography","low prostate specific antigen recurrence",{"date":577,"type":41},"2026-05-15",{"date":579,"type":41},"2025-05-20",{"date":581,"type":22},"2026-12-01",{"name":583,"class":48},"Massachusetts General Hospital",{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":23,"phases":593,"briefSummary":594,"conditions":595,"keywords":597,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":606,"leadSponsor":608,"locationsCount":4},"100637431","phase-2-a-study-of-mevrometostat-with-enzalutamide-in-people-with-prostate-cancer-who-have-previously-received-androgen-receptor-pathway-inhibitor-therapy-100637431","NCT07592910","A Study of Mevrometostat With Enzalutamide in People With Prostate Cancer Who Have Previously Received Androgen Receptor Pathway Inhibitor Therapy","A Phase 2, Open-label, Single-Arm Study of Mevrometostat Plus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer Following Prior Androgen Receptor Pathway Inhibitor Therapy (MOMENT)","MOMENT","Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Age 18 years or older\n* Diagnosis of prostate cancer (adenocarcinoma) confirmed by tissue sample, without neuroendocrine or small cell features\n* Currently taking or recently treated with enzalutamide, darolutamide, or apalutamide (within 30 days of screening) and willing to switch to or restart enzalutamide for this study\n* Cancer has spread to bone or soft tissue (metastatic disease), confirmed by imaging\n* ECOG performance status of 0, 1, or 2 (able to care for self and up and about more than 50% of waking hours)\n* Testosterone level less than 50 ng\u002FdL at screening, with ongoing hormone deprivation therapy or prior surgical castration\n* If receiving bone-protective therapy (e.g., denosumab or bisphosphonates), must be on a stable dose for at least 4 weeks\n* Evidence of cancer progression while on enzalutamide, darolutamide, or apalutamide, shown by rising PSA, worsening disease on imaging, or new bone lesions\n* Adequate organ function based on blood tests within 28 days of starting treatment, including adequate blood counts, kidney function, and liver function\n* Willing to use acceptable birth control during the study and for 30 days after the last dose\n\nExclusion Criteria:\n\n* History of myelodysplastic syndrome, acute myeloid leukemia, or other prior cancer (exceptions: non-melanoma skin cancer, carcinoma in situ, cancers more than 3 years ago with no recurrence, or early-stage cancers with low risk of recurrence)\n* Any medical or psychiatric condition, including active infection or recent suicidal ideation, that may make study participation unsafe\n* History of seizure or conditions that may increase seizure risk (e.g., prior stroke, significant brain trauma), or loss of consciousness or transient ischemic attack within 12 months\n* Untreated brain metastases, spinal cord compression, or clinically significant epidural disease\n* Use of 5-alpha reductase inhibitors, herbal medications, or supplements known to alter PSA levels within 4 weeks of starting treatment\n* AIDS-related illness or active hepatitis B or C (well-controlled HIV is allowed)\n* Known history of chronic liver disease (e.g., alcoholic liver disease, primary biliary cirrhosis, autoimmune hepatitis, Wilson's disease, hemochromatosis)\n* Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or prior gastric resection or lap-band surgery\n* Clinically significant cardiovascular disease within the past 6 months (e.g., heart attack, unstable angina, stroke, heart failure NYHA Class III\u002FIV, pulmonary embolism, significant arrhythmias), cardiac pacemaker, or QTcF greater than 480 msec on screening ECG\n* Prior or current use of PARP inhibitors and\u002For AKT inhibitors\n* Prior cancer progression on abiraterone (stopping abiraterone due to side effects is allowed)\n* Known allergy to any study drug\n* Blood transfusion within 28 days prior to screening blood tests\n* Use of another investigational drug within 4 weeks before starting study treatment\n* Any other condition that, in the opinion of the investigator, would prevent safe participation\n* Current use or anticipated need for strong CYP3A4\u002F5 inhibitors or inducers (other than enzalutamide) within 10 days or 5 half-lives prior to treatment start",{"count":60,"type":22},[25],"The purpose of this study is to find out whether mevrometostat in combination with enzalutamide delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have previously received enzalutamide, darolutamide, or apalutamide in the metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic castration-resistant prostate cancer (nmCRPC) setting but have not previously progressed on abiraterone.",[596,28],"Metastatic Castrate Resistant Prostate Cancer (mCRPC)",[598,599,600,601,590,602,64],"Mevrometostat","EZH2 inhibitor","Enzalutamide","ARPI resistance","mCRPC","2026-05-11",{"date":531,"type":41},{"date":122,"type":22},{"date":607,"type":22},"2029-08",{"name":47,"class":48},{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":92},"100635456","determining-individual-preferences-for-gynecomastia-avoidance-dingo---stage-1-100635456","NCT07552922","Determining INdividual Preferences for Gynecomastia avOidance (DINGO) - Stage 1","Determining INdividual Preferences for Gynecomastia avOidance (DINGO) - Qualitative Stage","DINGO","Inclusion Criteria:\n\n* Men with high-risk BCR PCa but no ADT+\u002F-ARPI experience.\n* Men with ADT+\u002F-ARPI experience who have experienced breast-related side effects from this treatment.\n\nExclusion Criteria:\n\n• Men receiving psychiatric care as a consequence of their prostate cancer diagnosis or treatment thereof.",{"count":618,"type":22},24,[168],"This study aims to explore the perceptions of men with prostate cancer (PCa) and high-risk biochemical recurrence (BCR) regarding the risk of breast-related side effects, including gynaecomastia, from treatment.",[28],[623,149,624,625,626,627],"gynaecomastia","LHRH","testosterone","breast","estrogen","2026-04-22",{"date":630,"type":41},"2026-04-27",{"date":632,"type":41},"2025-12-01",{"date":634,"type":22},"2026-11-30",{"name":636,"class":48},"St Vincent's Hospital, Sydney",{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":641,"acronym":642,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":18,"minAge":644,"maxAge":4,"enrollmentInfo":645,"targetDuration":4,"studyType":389,"phases":4,"briefSummary":647,"conditions":648,"keywords":652,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":673,"locationsCount":618},"100630230","study-of-the-epidemiological-clinical-diagnostic-and-therapeutic-characteristics-of-prostate-cancers-in-algeria-100630230","NCT07484971","Study of the Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Prostate Cancers in Algeria","CLIQQC","Inclusion Criteria:\n\n* Patients aged 19 years and older.\n* Diagnosis of prostate cancer confirmed histologically and\u002For biologically.\n* Patients followed in the participating oncology departments.\n* Written informed consent obtained.\n\nNon Inclusion Criteria:\n\n* Histological types other than carcinoma\n* Secondary tumors\n* Participation in an interventional study","19 Years",{"count":646,"type":22},2000,"The goal of this observational study is to describe the demographic, epidemiological, clinical, and outcome characteristics of patients with prostate cancer.\n\nIt also aims to analyze the diagnostic approaches and management strategies used in the care of these patients in Algeria.",[64,649,357,650,651,28],"Prostate Cancer (Diagnosis)","Prostate Cancer Patients Treated by Radiotherapy","Prostate Cancer Metastatic",[653,654,64,655,656,657,658,659,660,661,662,663,664,665,666],"oncology","patient outcome","Prostate Cancer in Algerian patients","Observational Study","Retrospective data","Treatment strategies","Diagnostic approaches","Clinical characteristics","Epidemiological data","Demographic data","Cross-sectional study","Real-world data","Algeria","Algerian Study","2026-04-14",{"date":669,"type":41},"2026-04-17",{"date":671,"type":41},"2025-07-21",{"date":211,"type":22},{"name":674,"class":48},"Société Algérienne de Formation et Recherche en Oncologie",{"id":676,"slug":677,"hasResults":12,"nctId":678,"briefTitle":679,"officialTitle":679,"acronym":680,"eligibilityCriteria":681,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":682,"targetDuration":684,"studyType":389,"phases":4,"briefSummary":685,"conditions":686,"keywords":687,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":691,"lastUpdatePostDateStruct":692,"startDateStruct":694,"completionDateStruct":696,"leadSponsor":698,"locationsCount":92},"100632684","prognostic-value-of-early-postoperative-prostate-specific-antigen-for-oncological-outcomes-after-radical-prostatectomy-100632684","NCT07516886","Prognostic Value of Early Postoperative Prostate-Specific Antigen for Oncological Outcomes After Radical Prostatectomy","PPSARP","Inclusion Criteria:\n\n* Patient is an adult biological male.\n* Patient has morphologically confirmed and untreated prostate cancer.\n* Patient who will be treated with open, laparoscopic or robot-assisted laparoscopic radical prostatectomy.\n* Patient is informed about this observational study and has signed the informed consent form.\n\nExclusion Criteria:\n\n* Patient has radiologically of morphologically confirmed prostate cancer metastases before the operation.\n* Patient received neoadjuvant prostate cancer treatment.\n* Patient is set to receive adjuvant treatment.\n* Patient has any contraindications for the operation.",{"count":683,"type":22},500,"10 Years","This prospective observational study aims to evaluate the prognostic significance of early postoperative prostate-specific antigen (PSA) levels in patients undergoing radical prostatectomy for prostate cancer.\n\nNo investigational interventions will be performed. All diagnostic procedures, follow-up assessments, and treatments will be conducted in accordance with standard clinical practice and established prostate cancer management guidelines. Participation in the study will not influence treatment decisions.",[357,28,649,572,178],[149,688,689,690],"persistent prostate-specific antigen","prostate-specific antigen","radical prostatectomy","2026-04-01",{"date":693,"type":41},"2026-04-08",{"date":695,"type":41},"2024-01-22",{"date":697,"type":22},"2039-07",{"name":699,"class":48},"Lithuanian University of Health Sciences",{"id":701,"slug":702,"hasResults":12,"nctId":703,"briefTitle":704,"officialTitle":704,"acronym":705,"eligibilityCriteria":706,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":707,"targetDuration":4,"studyType":23,"phases":708,"briefSummary":709,"conditions":710,"keywords":4,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":711,"lastUpdatePostDateStruct":712,"startDateStruct":714,"completionDateStruct":716,"leadSponsor":718,"locationsCount":92},"100632589","phase-2-molecular-imaging-informed-radiation-dose-escalation-to-sites-of-recurrent-disease-and-de-escalation-to-uninvolved-areas-in-salvage-radiotherapy-using-sbrt-for-prostate-cancer-to-reduce-treatment-toxicity-100632589","NCT07515651","Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy Using SBRT for Prostate Cancer to Reduce Treatment Toxicity","MIDAS-SBRT","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Histologically proven initial diagnosis of adenocarcinoma prostate cancer.\n* Radical prostatectomy \\> 6 months prior to commencing SBRT.\n* Biochemical relapse with local and\u002For regional recurrence proven with PSMA PET\n* ECOG 0-1.\n\nExclusion Criteria:\n\n* Presence of para-aortic lymph nodes or distant metastasis.\n* Chronic pelvic inflammatory disease.\n* Contraindication for radiation treatment.\n* Previous radiation treatment within the pelvis.",{"count":199,"type":22},[25],"This is a single arm trial that is recruiting a total of 50 participants that have been diagnosed with prostate bed (where the prostate was taken out) or regional (surrounding lymph nodes) recurrence of a prostate cancer following surgery. Salvage radiation treatment represents the main treatment option, with long-term cure rates on the order of 70%. Currently, salvage radiation treatment to the prostate bed and the pelvic lymph nodes is delivered using external beam radiation therapy (EBRT) in 20-33 sessions, over 4-6.5 weeks. Potential study participants have undergone a PSMA PET scan, which has found recurrent cancer in the prostate bed or lymph nodes. This study will investigate personalizing your radiation treatment based on this information. Participants on this study will receive lower than standard radiation dose to areas of the surgical site which do not show evidence of disease on the scan.\n\nThis personalized radiotherapy will be delivered in 5 treatments over two weeks, rather than the four to 6 weeks which is the current standard of care. Participants will have a routine history, blood collection for PSA and hormone levels, toxicity assessment, and EPIC-26 \\& IPSS questionnaires at each follow-up visit. These will take place at 1, 3, 6, 12, 24, 36, and 60 months after radiation treatment.",[28],"2026-03-31",{"date":713,"type":41},"2026-04-07",{"date":715,"type":22},"2026-05-01",{"date":717,"type":22},"2034-05-01",{"name":189,"class":48},{"id":720,"slug":721,"hasResults":12,"nctId":722,"briefTitle":723,"officialTitle":724,"acronym":4,"eligibilityCriteria":725,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":726,"targetDuration":4,"studyType":23,"phases":728,"briefSummary":729,"conditions":730,"keywords":731,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":735,"startDateStruct":737,"completionDateStruct":739,"leadSponsor":740,"locationsCount":742},"100618467","phase-2-a-biomarker-study-in-men-with-localized-prostate-cancer-treated-with-aglatimagene-besadenovec-100618467","NCT07332000","A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec","A Biomarker Study in Men With Localized, Favorable, Intermediate-risk Prostate Cancer Treated With Aglatimagene Besadenovec","Inclusion Criteria:\n\n1. Participants must give study-specific informed consent prior to enrollment\n2. Histologically confirmed adenocarcinoma of the prostate\n3. Participants meeting National Comprehensive Cancer Network (NCCN) intermediate-risk criteria\n4. Participants must be planning and medically able to undergo standard or moderate hypofractionated prostate-only EBRT (treatment and control group) and able to tolerate multiple transrectal ultrasound guided injections (treatment group only)\n5. 18 years of age or older\n6. Performance status must be Eastern Cooperative Oncology Group 0-2\n7. The following laboratory criteria must be met (treatment group only):\n\n   1. Aspartate aminotransferase (AST) \\\u003C 3 x upper limit of normal\n   2. Serum creatinine \\\u003C 2 mg\u002FdL\n   3. Calculated creatinine clearance \\> 30 mL\u002Fmin\n   4. White blood cells \\> 3000\u002Fmm3\n   5. Platelets \\>100,000\u002Fmm3\n\nExclusion Criteria:\n\n1. Active liver disease, including known cirrhosis or active hepatitis\n2. Participants on systemic corticosteroids (\\> 10 mg prednisone per day) or other immunosuppressive drugs\n3. Known HIV+ participants\n4. Regional lymph node involvement or distant metastases\n5. Participants planning to receive whole pelvic irradiation\n6. Other current malignancy (except squamous or basal cell skin cancers)\n7. Other serious co-morbid illness or compromised organ function that, in the opinion of the Investigator, would interfere with treatment or follow-up. For example, participants with diseases that preclude radiation therapy to the prostate such as severe prostatitis and inflammatory bowel disease.\n8. Prior treatment for prostate cancer except transurethral resection of the prostate (TURP). If prior TURP, participants must be deemed able to receive multiple intra-prostatic injections by the Investigator.\n9. Participants who had or plan to have orchiectomy as the form of hormonal ablation\n10. Known sensitivity or allergic reactions to acyclovir or valacyclovir (treatment group only)",{"count":727,"type":22},45,[25],"Phase 2a, open-label, multi-center study evaluating biomarkers and biodistribution of aglatimagene besadenovec plus valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT).",[650,28],[732,733,64,734],"Biomarkers","Viral Shedding","Aglatimagene Besadenovec",{"date":736,"type":41},"2026-03-20",{"date":738,"type":41},"2025-10-30",{"date":122,"type":22},{"name":741,"class":127},"Candel Therapeutics, Inc.",7]