[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"localized-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:localized-prostate-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,45,78,110,149,176,201,220,249,281,302,320,344],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100651261","sonablate-hifu-international-registry-for-pc--bph-patients-100651261",false,"NCT07757490","Sonablate HIFU International Registry for PC & BPH Patients","SONAFUSION Registry (Long-term Evaluation of Sonablate High-Intensity Focused Ultrasound for the Treatment of Prostate Cancer and Benign Prostatic Hyperplasia)","SONAFUSION","Inclusion Criteria:\n\n* Male with diagnosed localized prostate cancer or BPH (benign prostatic hyperplasia)\n* Having undergone Sonablate HIFU ablation as part of standard clinical care, with all central data transmission subject to a mandatory 180-day post-procedure delay.\n\nExclusion Criteria:\n\n* Prostate size or lesion location precluding effective HIFU target acquisition (prostate volume \\>100 CC for prostate cancer or \\>80 CC for BPH)\n* Confirmed metastatic prostate cancer\n* Prior radical prostatectomy\n* Prostates with large calcifications (\\>10mm causing shadowing)\n* Prior rectal wall surgery or inability to undergo transrectal ultrasound","MALE","18 Years",{"count":20,"type":21},10000,"ESTIMATED","10 Years","OBSERVATIONAL","The SONA FUSION Registry is an observational study designed to evaluate the long-term effectiveness and safety of the Sonablate High-Intensity Focused Ultrasound (HIFU) system. This study focuses on adult men who have been treated for localized prostate cancer, benign prostatic hyperplasia (BPH) with urinary symptoms, or a combination of both conditions. The registry collects real-world medical data from multiple clinics globally to better understand how well the HIFU treatment controls disease and affects urinary and sexual function over a 10- to 20-year period.\n\nThe study includes two groups of participants: a retrospective group of patients who previously received treatment, and a prospective group of newly treated patients receiving standard clinical care. No experimental interventions are assigned for the purpose of this study. To protect participant privacy, all medical data is completely de-identified and stripped of direct identifiers before being securely transferred to the central coordinating center at Indiana University. The ultimate goal of this research is to improve patient care protocols, advance men's health knowledge, and establish evidence-based guidelines for minimally invasive prostate treatments.",[26,27,28],"Localized Prostate Cancer","BPH (Benign Prostatic Hyperplasia)","Prostate Cancer; Benign Prostatic Hyperplasia",[30,31],"HIFU, LOFU, High Intensity Focused Ultrasound, Sonablate, Directional Compression, Bolus Guide, prostate cancer, BPH, Histoblast, Sonatripsy","High-Intensity Focused Ultrasound, HIFU, Sonablate, Lower Urinary Tract Symptoms, Minimally Invasive, Prostate Ablation","RECRUITING","2026-08-11",{"date":35,"type":36},"2026-08-13","ACTUAL",{"date":38,"type":36},"2015-01-01",{"date":40,"type":21},"2035-12",{"name":42,"class":43},"Sonablate","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100643140","water-iv-pca-as-sub-study-100643140","NCT07650448","WATER IV PCa (AS Sub-study)","WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer","Inclusion Criteria:\n\n1. Biological male with age ≥ 45 years at the time of consent\n2. Biopsy positive Grade Group 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS\u002FLikert ≥ 3)\n3. First prostate cancer diagnoses within 18 months (545 days) of consent\n4. Are candidates for active surveillance\n5. Clinical Stage ≤ T2c\n6. PSA \\\u003C 15 ng\u002Fml\n7. Prostate volume ≥25 ml\n\nExclusion Criteria:\n\n1. Any prior or current local or systemic treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation, hormone therapy or chemotherapy.\n2. Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment.\n3. Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion.\n4. Patient is unwilling to accept a blood transfusion if required.\n5. Any condition or history of illness or surgery that may pose an additional risk to patients undergoing the Aquablation or radical prostatectomy procedure such as:\n\n5a. Medical conditions that preclude the use of anesthesia; 5b. Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of rectal injury (i.e. fistula formation); 5c. Patient is unable to stop anticoagulants or antiplatelet agents prior to study treatment per standard of care; 5d. Any other condition or history of infection, illness or surgery that in the opinion of the investigator might affect the outcome of the study procedure, study conduct, and study results; or pose additional risks to the patient (e.g., other cancer, active urethral stricture disease).\n\n6\\. Patients who are unable to provide informed consent due to cognitive impairment, legal status (such as incarceration), or other factors limiting autonomy or unwilling or unable to follow study instructions including randomization and complete all required study visits through 10 years. This includes individuals with severe cognitive disabilities, those under legal guardianship, or those currently incarcerated.\n\n7\\. Patient currently participating in other studies unless approved by Sponsor in writing.\n\n8\\. More than one complete biopsy beyond the diagnostic biopsy comprising both a systematic biopsy and biopsy of any MRI visible lesion (PI-RADS\u002FLikert ≥ 3).\n\n9\\. GG2 disease with PSA ≥ 10 OR stage ≥ T2b OR ≥ 50% of biopsy cores positive (multiple cores taken from any MRI visible lesion are counted as one continuous core).","45 Years",{"count":54,"type":21},333,"INTERVENTIONAL",[57],"NA","The WATER IV study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with localized prostate cancer.",[26],[61,62,63,64,65,66],"Aquablation","AquaBeam","HYDROS","Active Surveillance","Prostate Cancer","Aquablation Therapy","NOT_YET_RECRUITING","2026-07-31",{"date":70,"type":36},"2026-08-04",{"date":72,"type":21},"2026-09",{"date":74,"type":21},"2038-12",{"name":76,"class":43},"PROCEPT BioRobotics",25,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":55,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":44},"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":87,"type":21},8,[57],"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.",[91,26],"Prostate Cancer (Adenocarcinoma)",[65,93,94,95,96,26,97,98,99],"Gallium Ga 68 Gozetotide","Positron Emission Tomography Magnetic Resonance Imaging","Multiparametric Magnetic Resonance Imaging","Focal Therapy","Intermediate-Risk Prostate Cancer","Radical Prostatectomy","Diagnostic Imaging","2026-07-30",{"date":102,"type":36},"2026-08-05",{"date":104,"type":21},"2026-09-01",{"date":106,"type":21},"2027-12-31",{"name":108,"class":109},"University Health Network, Toronto","OTHER",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":55,"phases":120,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":147,"locationsCount":44},"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":119,"type":21},1000,[121,122],"PHASE2","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.",[91,125,126,127,26],"Prostate Brachytherapy","Stereotactic Body Radiation Therapy (SBRT)","Dose Escalation: Solid Tumors",[129,130,131,132,133,134,135,136,137,138,139,140],"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":143,"type":36},"2026-07-21",{"date":145,"type":36},"2026-03-19",{"date":40,"type":21},{"name":148,"class":109},"Affidea Nu-med Center of Oncological DIagnostics and Therapy",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":55,"phases":159,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":44},"100451172","phase-2-18f-dcfpyl-imaging-as-a-method-to-assess-treatment-response-to-stereotactic-body-radiation-therapy-100451172","NCT05155046","18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy","Phase II Trial of 18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy","* INCLUSION CRITERIA:\n* Biopsy proven localized prostate cancer in whom stereotactic body radiation treatment (SBRT) with or without neoadjuvant androgen deprivation therapy (ADT) is planned for definitive management (NIH laboratory of pathology confirmation is not required).\n* Must have at least 1 MRI detected, biopsy proven localized prostate cancer.\n* Age \\>= 18 years\n* ECOG performance status \\\u003C= 2\n* For individuals with evidence of human immunodeficiency virus (HIV) infection, individuals must be on effective anti-retroviral therapy with undetectable viral load within the prior 6 months are eligible.\n* For individuals with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* For individuals with a history of hepatitis C virus (HCV), the infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Men must agree to use adequate contraception with their partner (hormonal or barrier method of birth control; abstinence) for the duration of study participation and 2 months after the last 18F-DCFPyL scan.\n\nEXCLUSION CRITERIA:\n\n* Receiving prior androgen deprivation therapy, radiotherapy, or surgery for prostate cancer.\n* Any condition that is likely to interfere with study procedures or results.\n* Individuals in whom pelvic nodal irradiation is planned.\n* Serum creatinine \\> 2 times the upper limit of normal.\n* Weighing \\> 350 lbs (weight limit for scanner table), or unable to fit in imaging gantry.\n* Evidence of tumor spread beyond the prostate\u002Fseminal vesicles (lymph nodes, metastases).\n* Contraindications to radiation or SBRT.","120 Years",{"count":158,"type":21},130,[121],"Background:\n\nIdentifying medium- and high-risk prostate cancer early may allow for treatments to work. But identification can be hard. Researchers want to see if a radiotracer used during PET scans can help.\n\nObjective:\n\nTo test how an imaging agent called 18F-DCFPyL detects response to standard prostate cancer treatment.\n\nEligibility:\n\nPeople ages 18 and older with newly diagnosed prostate cancer who have no evidence of distant metastatic disease and plan to get stereotactic body radiation therapy (SBRT) with or without androgen deprivation therapy (ADT).\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nMRI\n\nParticipants will have baseline MRI and PET\u002FCT scans. For the MRI, they may get a contrast agent by IV injection. For the PET\u002FCT scan, they will get an IV injection of 18FDCFPyL. About 1 to 2 hours later, they will get the PET\u002FCT scan. During the scans, participants will lie on their back and remain still for 45 minutes to 1 hour. These scans will be repeated at different points during the study.\n\nParticipants will get SBRT with or without ADT.\n\nParticipants will complete questionnaires about their quality of life.\n\nParticipants will be asked about any symptoms they are having. They will also be asked about medications they are using. They may have a physical exam.\n\nParticipants will give blood and urine samples. They will give a tumor sample from a biopsy they have had in the past.\n\nAfter treatment, participants will have follow-up visits. These will occur 1 month after treatment, then every 3 months for a year, and then every 6 months for 1 more year.",[26],[26,129,163,164,165],"Prostate Specific Membrane Antigen","Androgen Deprivation Therapy","longitudinal quality of life","2026-07-15",{"date":168,"type":36},"2026-07-16",{"date":170,"type":36},"2022-08-31",{"date":172,"type":21},"2029-12-31",{"name":174,"class":175},"National Cancer Institute (NCI)","NIH",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":55,"phases":185,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"100348780","phase-2-neoadjuvant-atezolizumab-based-combination-therapy-in-men-with-localized-prostate-cancer-prior-to-radical-prostatectomy-100348780","NCT03821246","Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy","An Open-Label Multi-Center Phase II Study of Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the prostate.\n\n   a. Subjects with small cell or neuroendocrine PC are not eligible.\n2. Eligible for radical prostatectomy as determined by urologic oncology surgeon, and subject consents to proceeding with radical prostatectomy.\n\n   a. Deemed by urologic oncology surgeon to be appropriate for a \"window-of-opportunity\"study.\n3. Only patients with high-risk disease are eligible for the safety lead-in for each cohort. Patients with intermediate-risk disease will be included after interim analyses is complete for the corresponding cohort and the PI has determined that it is safe to do so.\n4. Availability of a representative tumor specimen that is suitable for the planned study analyses, as determined by the Principal Investigator.\n\n   1. A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 15 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report prior to study treatment. If only 10-14 slides are available, the patient may still be eligible for the study, after Principal Investigator approval has been obtained.\n   2. If archival tumor tissue is unavailable or is determined to be unsuitable for required testing, tumor tissue must be obtained from a biopsy performed at screening. Refer to Section 6.3 for additional information on tumor specimens collected at screening.\n5. Subjects have not received any prior systemic or locally directed therapy for PC (see exclusion criteria).\n6. Age \\>= 18 years\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n8. Requirements for organ and marrow function:\n\n   * Hemoglobin \\>= 9 g\u002FdL\n   * \\- Participants must not have been transfused within 2 weeks prior to screening to meet this criterion\n   * Absolute neutrophil count \\>= 1,500\u002Fmicroliter (uL) without granulocyte colonystimulating factor support\n   * Absolute lymphocyte count \\>= 500\u002FuL\n   * Platelets \\>= 100,000\u002FuL without transfusion\n   * Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN) (known Gilbert disease: \\\u003C 3 x ULN)\n   * Alkaline phosphatase \\\u003C 2 x institutional ULN\n   * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) =\\\u003C 2 x institutional ULN\n   * Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) =\\\u003C 2 x institutional ULN\n   * International normalized ratio (INR) or activated partial thromboplastin time (aPTT) \\\u003C 1.5 x institutional ULN for subjects not receiving therapeutic anticoagulation\n   * Creatinine clearance \\>= 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n   * Serum creatinine \\\u003C=1.6 mg\u002FdL (141 μmol\u002FL) in female patients and ≤1.9 mg\u002FdL (168 μmol\u002FL) in male patients . Patients with serum creatinine values exceeding limits may be eligible for the study if their estimated glomerular filtration rates (GFR) are \\>30\n9. Testosterone level \\> 150 ng\u002FdL.\n10. Contraception: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm as defined below:\n\n    1. With female partners of childbearing potential: men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 4 months after the last dose of study treatment. Men must refrain from donating sperm during the same period\n    2. With pregnant female partners: men must remain abstinent or use a condom during the treatment period and for 4 months after the last dose of study treatment to avoid exposing the embryo\n    3. Abstinence: the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception\n11. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen \\> 3 months.\n12. Ability to understand a written informed consent document, and the willingness to sign it.\n13. Ability to comply with the study protocol, in the investigator's judgment.\n\nExclusion Criteria:\n\n1. Evidence of metastatic disease as determined by standard staging scans.\n\n   a. Staging scans should be performed per urologic standard of care for patients undergoing radical prostatectomy \\[per American Urological Association (AUA)\u002FNational Comprehensive Cancer Network (NCCN) guidelines\\].\n2. Not a candidate for radical prostatectomy as determined by treating urologic oncology surgeon.\n3. Any prior systemic therapy for PC, including antiandrogens, androgen deprivation therapy \\[gonadotropin-releasing hormone (GnRH) agonist or antagonist\\], chemotherapy, targeted therapy, immunotherapy, OR radiopharmaceuticals.\n\n   a. Subjects who are on finasteride or dutasteride must discontinue therapy and undergo a washout period of 6 weeks to become eligible for the study. Screening procedures should begin following the washout period.\n4. Prior radiotherapy for PC.\n5. Any history of prior malignancy, except:\n\n   1. Non-melanoma skin cancer treated with curative intent\n   2. Carcinoma-in-situ (CIS) treated with curative intent, without evidence of recurrence or disease progression for 3 years\n   3. Appropriately treated Stage I uterine cancer\n   4. All other cancer: treated with curative intent and without evidence of disease on standard of care follow-up for 5 years\n6. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n   1. Subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement therapy, with a stable dose \\> 3 months, are eligible for the study\n   2. Subjects with controlled type 1 diabetes mellitus who are on an insulin regimen, with a Glycated hemoglobin (hemoglobin A1C) \\\u003C 7.0 are eligible for the study. All subjects with controlled type 2 diabetes mellitus are eligible for the study\n   3. Subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded from the study) are eligible for the study provided all of the following conditions are met:\n\n      * Rash covers \\\u003C 10% of body surface area\n      * Disease is well controlled at baseline and requires only low-potency topical steroids\n      * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n7. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or any evidence of active, non-infectious pneumonitis requiring corticosteroids.\n8. History of prior positive human immunodeficiency virus (HIV) test.\n9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (chronic or acute).\n\n   1. Subjects with a past or resolved HBV infection are eligible for this study.\n   2. HCV positivity is defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening; the HCV RNA test will only be performed for subjects who have a positive HCV antibody test.\n10. Significant cardiovascular disease, such as New York Heart Association class III or greater cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n11. Active chronic obstructive pulmonary disease (COPD) requiring use of home oxygen (O2) or systemic steroid therapy \\> 10 mg prednisone (or equivalent) daily.\n12. Asthma requiring systemic corticosteroids \\> 10 mg prednisone (or equivalent) daily. Inhaled corticosteroids for the treatment of asthma are permitted.\n13. Major surgical procedure (including joint surgery) other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study.\n\n    a. Placement of central venous access catheter (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted.\n14. Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n15. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.\n16. Prior allogeneic stem cell or solid organ transplantation.\n17. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study or within 5 months after the last dose of atezolizumab. Note: Because IL-6 inhibition may interfere with the normal immune response to new antigen, patients should be brought up to date on all recommended vaccinations, except for live vaccines, prior to initiation of therapy with tocilizumab to maximize vaccine response.\n18. Treatment with investigational therapy within 28 days prior to initiation of study treatment.\n19. Prior treatment with adenosine-axis inhibitors, cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), ant-PD-1, and anti-PD-L1 therapeutic antibodies.\n20. Treatment with systemic immunostimulatory agents \\[including, but not limited to, interferon and interleukin 2 (IL-2)\\] within 4 weeks or five half-lives of the drug (whichever is longer) prior to initiation of study treatment.\n21. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)- agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study, with the following exceptions:\n\n    1. Patients who receive acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study\n    2. Patients who receive mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma (=\\\u003C 10 mg prednisone or equivalent), or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency (=\\\u003C 10 mg prednisone or equivalent) are eligible for the study.\n22. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n23. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.\n24. Known allergy or hypersensitivity to any of the study drugs of their excipients.\n25. Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples include: CAMPATH, anti-cluster of differentiation 4 (CD4), anti-cluster of differentiation 5 (CD5), anti-cluster of differentiation 3 (CD3), anti-Cluster of Differentiation 19 (CD19) and anti-Cluster of Differentiation 20 (CD20) within 5 years prior to first dose of study treatment.\n26. Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.\n27. Previous treatment with tocilizumab (an exception to this criterion may be granted for single dose exposure upon application to the Sponsor-Investigator on a case-by-case basis).\n28. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation within 5 years prior to first dose of study treatment.\n29. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.\n30. Evidence of serious uncontrolled concomitant, nervous system, pulmonary, renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn's disease).\n31. Any history of recent serious bacterial, viral, fungal, or other opportunistic infections.\n32. Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.\n33. Any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial.\n34. Pregnant women or nursing (breast feeding) mothers.\n35. Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation.\n36. Patients with lack of peripheral venous access\n\n    Additional Exclusion Criteria for Cohort B (atezolizumab + etrumadenant):\n37. Treatment with known P-glycoprotein (P-gp) substrates with a narrow therapeutic window, administered orally (e.g., digoxin) within 4 weeks (for investigational drugs when half-life is unknown or not accurately determined) or 5 drug-elimination half-lives of the drug (when half-life is determined), whichever is longer, or if it is a marketed drug, then 5 drug-elimination half-lives of the drug, prior to initiation of study treatment.\n38. Treatment with known strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort) and strong CYP3A4 inhibitors (eg,clarithromycin, grapefruit juice, itraconazole, ketoconazole, posaconazole, telithromycin,and voriconazole) within 4 weeks (for investigational drugs when half-life is unknown or not accurately determined) or 5 drug-elimination half-lives of the drug (when half-life is determined), whichever is longer, or if it is a marketed drug, then 5 drug-elimination half-lives of the drug, prior to initiation of study treatment.\n39. Treatment with known breast cancer resistance protein (BCRP) substrates with a narrow therapeutic window, administered orally (e.g., prazosin, rosuvastatin) within 4 weeks (for investigational drugs when half-life is unknown or not accurately determined) or 5 drug-elimination half-lives of the drug (when half-life is determined), whichever is longer, or if it is a marketed drug, then 5 drug-elimination half-lives of the drug, prior to initiation of study treatment.\n\n    Additional Exclusion Criteria for Cohort C (atezolizumab + tocilizumab):\n40. Known active infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, including, but not limited to, TB (i.e., has signs and symptoms of TB) and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds.",{"count":184,"type":21},68,[121],"This phase II trial studies how well atezolizumab works alone or in combination with etrumadenant or tocilizumab in treating men with localized prostate cancer before radical prostatectomy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Androgens can cause the growth of prostate cancer cells. IL-6 is expressed by prostate cancer and within the tumor microenvironment and shown to enhance prostate cancer and disease progression. Treatment with an anti-IL-6 antibody such as tocilizumab may inhibit cancer progression. Giving atezolizumab in combination with etrumadenant or tocilizumab may work better in treating prostate cancer.",[188,65,26],"Prostate Adenocarcinoma",[190],"Neoadjuvant therapy","2026-06-02",{"date":193,"type":36},"2026-06-04",{"date":195,"type":36},"2019-10-30",{"date":197,"type":21},"2027-04-30",{"name":199,"class":109},"David Oh",2,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":55,"phases":210,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":44},"100579499","phase-3-is-adaptive-sbrt-for-prostate-vs-image-guided-radiotherapy-a-true-evolution-aspire-100579499","NCT06825091","Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)","ASPIRE","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Histologic diagnosis of prostate adenocarcinoma\n3. Localized prostate cancer\n4. Low risk, intermediate risk, or high risk allowed\n5. Patient planned for prostate SBRT\n\nExclusion Criteria:\n\n1. Planned for elective nodal irradiation\n2. Contraindications to radiotherapy\n3. Patients with bilateral hip replacements, as they are ineligible for adaptive treatments at present time (either MR-guided or CT-guided)",{"count":209,"type":21},320,[122],"The ASPIRE study is a Phase III randomized, single-center study designed to evaluate whether adaptive stereotactic body radiotherapy (SBRT) offers superior clinical benefits compared to standard image-guided SBRT for patients with localized prostate cancer. It aims to explore whether adaptive SBRT can improve urinary outcomes while maintaining effective cancer control.\n\nThis interventional study is randomized, single-institution, and includes 320 participants with localized prostate cancer. Patients will be stratified based on fractionation schedules (5 vs. 7 fractions), use of rectal spacers, androgen deprivation therapy (ADT), and baseline alpha receptor antagonist use. Participants will be randomized to receive either adaptive SBRT or standard image-guided SBRT, with both arms adhering to established dosing protocols.\n\nInclusion criteria includes an age greater than 18 years, diagnosed with localized prostate adenocarcinoma, and an ECOG performance status of 0-1, Eligible for prostate SBRT. The exclusion criteria includes patients who plan for elective nodal irradiation and contraindications to radiotherapy or MRI (for MR-Linac patients).",[26,130],"2026-05-29",{"date":191,"type":36},{"date":216,"type":36},"2025-02-04",{"date":218,"type":21},"2030-02-04",{"name":108,"class":109},{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":55,"phases":229,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":44},"100590389","oxybutynin-er-to-promote-early-continence-recovery-after-robotic-prostatectomy-a-randomized-controlled-trial-100590389","NCT06966778","Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial","A Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy of Oxybutynin Chloride Extended-Release Tablets to Improve Early Continence Recovery After Robotic Prostatectomy","Inclusion Criteria:\n\n* Diagnosis: Patients with localized prostate cancer who are scheduled to undergo robot-assisted radical prostatectomy (RARP).\n* Age: Participants must be 18 years or older, with no upper age limit.\n* Consent: Participants must provide written informed consent before undergoing any study procedures.\n* Ability to Follow Protocol: Participants must be able to follow the protocol procedures throughout the study.\n\nExclusion Criteria:\n\n* Surgical Complications: Participants who experience surgical complications during or after RARP requiring extraordinary medical or surgical treatment.\n* Other Urinary Conditions: Participants with other diseases causing lower urinary tract symptoms (LUTS) or bladder pain, including:\n* \\- Benign prostatic hyperplasia (BPH), chronic prostatitis, interstitial cystitis, painful bladder syndrome, or urinary tract infection.\n* \\- Overactive bladder or any other condition affecting bladder function.\n* Chronic Medication: Participants with long-term use of medications such as:\n* \\- Alpha-blockers, antimuscarinics, or anticholinergics.\n* Glaucoma: Participants with narrow-angle glaucoma.\n* Urinary Retention: Participants with a history of urinary retention.\n* Gastrointestinal Motility Issues: Participants with severe conditions affecting gastrointestinal motility.\n* Concurrent Medications: Participants who are taking medications that are prohibited by the study protocol (e.g., cholinergic drugs, azole antifungals, smooth muscle relaxants).",{"count":228,"type":21},135,[57],"The goal of this double-blind, randomized, placebo-controlled study is to evaluate whether oxybutynin chloride extended-release tablets can improve early continence recovery after robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer.\n\nThe main questions it aims to answer are:\n\n\\[Does oxybutynin chloride improve continence recovery after RARP compared to a placebo?\\] \\[What are the predictors of continence recovery?\\]\n\nResearchers will compare the treatment group (oxybutynin chloride 10 mg\u002Fday) with the control group (placebo) to assess differences in continence outcomes.\n\nParticipants will:\n\n\\[Take the assigned medication (oxybutynin chloride or placebo) daily for 1-3 months until continence recovery.\\] \\[Complete surveys (e.g., IPSS, IIEF, ICIQ) at several time points post-surgery, including before surgery, 10 days after Foley catheter removal, and up to 12 months.\\] \\[Record any adverse events or concomitant medication use.\\]\n\nSafety and tolerability will be monitored, and statistical analyses will determine the efficacy and predictors of continence. The study adheres to ethical principles, local regulations, and GCP guidelines.",[26,232],"Postoperative Urinary Incontinence",[26,234,235,232,236,237,238,239],"Robot-Assisted Radical Prostatectomy (RARP)","Early Continence Recovery","Oxybutynin Chloride","Extended-Release Tablets","Double-Blind Randomized Study","Placebo-Controlled Trial","2026-03-12",{"date":242,"type":36},"2026-03-16",{"date":244,"type":36},"2025-09-15",{"date":246,"type":21},"2028-12-31",{"name":248,"class":109},"National Taiwan University Hospital",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":55,"phases":259,"briefSummary":260,"conditions":261,"keywords":264,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":44},"100525078","the-precision-study-3-fractions-of-prostate-sbrt-and-raypilot-hypocath-image-guidance-100525078","NCT06117059","The PRECISION Study: 3 Fractions of Prostate SBRT and RayPilot HypoCath Image Guidance","The PRECISION Study: A Phase II Study of 3 Fractions of Prostate SBRT With RayPilot System and HypoCath Image Guidance for Men With NCCN Low or Intermediate Risk Prostate Cancer","PRECISION","Inclusion Criteria:\n\n* low and favorable intermediate NCCN Criteria patients\n* Prostate volume under 80cc\n* IPSS under 20\n* Q-max above 10cc per second and urinary residual less than 150mls\n* No TURP\n* No hip replacements\n* No previous radiotherapy to the pelvis\n* No active second malignancy except skin SCC or BCC for the last 2 years\n* No history of inflammatory bowel disease\n* No co-morbid illness that would make compliance to treatment difficult\n* Able to give informed consent\n\nExclusion Criteria:\n\n* T3a or above\n* Gleason 4+3=7\n* PSA\\>20ng\u002Fml",{"count":258,"type":21},100,[57],"The investigators want to investigate whether it is possible to reduce the number of curative radiotherapy doses from 5 to only 3 for men with localized early prostate cancer. The aim of the study is to ensure that the side effects of the 3-dose treatment are the same or potentially lower than those already published when using the 5-dose treatment as used in the UK PACE-B trial (NCT01584258). The name of this type of radiotherapy is Stereotactic Body Radiotherapy (SBRT) or participants may see it referred to as Stereotactic Ablative Radiotherapy (SABR). The study is a two-stage single arm Phase II study open to those Centres that use the RayPilot HypoCath tumour tracking system (Micropos Medical). This commercially available system was not available at the time of the original PACE-B study. The system acts like a Global Positioning Device (GPS) to continuously track the prostate position during radiotherapy. If the prostate moves more than 2mm (about 0.08 in) from its intended position during the treatment, then the radiotherapy team are alerted, and the treatment halted until the prostate moves back into the correct position. The ability to understand exactly where the prostate is throughout the treatment ensures the intended dose hits the cancer and does not accidentally increase the dose to the nearby bladder and rectum. The system is a modification of a standard urinary catheter which sits within the bladder with the GPS placed within the wall of the catheter as it passes through the prostate. The investigators are not testing the system as it is commercially available but using it to improve the accuracy of radiotherapy delivery, reducing the number of days of treatment, minimizing side effects and helping ease the burden on busy radiotherapy Departments.",[26,262,263],"Low Risk Prostate Cancer","Intermediate Risk Prostate Cancer",[131,265,266,267,268,269,270],"SABR","PROSTATE CANCER","RayPilot","HypoCath","Continuous tracking","3 fractions","2026-01-08",{"date":273,"type":36},"2026-01-12",{"date":275,"type":36},"2024-11-01",{"date":277,"type":21},"2027-11-01",{"name":279,"class":280},"NHS Lothian","OTHER_GOV",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":55,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":44},"100541141","hypofractionated-post-prostatectomy-radiotherapy-hyportfor-localized-prostate-cancer-100541141","NCT06325995","Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer","Safety and Efficacy Study of Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer: a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* European Cooperative Oncology Group score(ECOG):≤ 2;\n* Patients with pathologically confirmed prostate cancer and completed radical resection of prostate cancer;\n* Postoperative pathological staging of AJCC version 8 pT 3a, pT 3b, pT 4, margin (+), or N1; or serum PSA≥0.1 ng\u002Fml 6 weeks after surgery; or serum PSA \\\u003C0.1 ng\u002Fml 6 weeks after surgery, subsequent follow-up process revealed two consecutive sustained PSA increases (≥0.1 ng \u002F ml) and no clinical imaging (Whole Body Scan (ECT), magnetic resonance imaging (MRI),68Ga PSMA PET \u002F CT, etc.) signs of metastasis;\n* Expected survival time \\>5 years;\n* Patients who voluntarily accept the experimental study protocol after informing the existing treatment options;\n\nExclusion Criteria:\n\n* poor recovery of postoperative urinary control;\n* a previous history of pelvic and abdominal radiotherapy;\n* Participate in other clinical trials that are mutually exclusive with the study intervention within 4 weeks prior to the start of the study;\n* Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and\u002For positive syphilis;\n* Patients that the investigator considers unsuitable to participate in the clinical trial; patients with other serious systemic diseases, evaluation and compliance of the trial, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary, and other systemic diseases;\n* Patients with contraindications related to radiotherapy;\n* Written informed consent could not be provided, and treatment compliance was poor.Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.",{"count":289,"type":21},428,[57],"The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer.\n\nAccumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT is still on its way.\n\nIt is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ) with or COPORT may work better in treating patients with prostate cancer.",[26],"2024-08-22",{"date":295,"type":36},"2024-08-26",{"date":297,"type":36},"2024-02-01",{"date":299,"type":21},"2031-02-01",{"name":301,"class":109},"Changhai Hospital",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":55,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":44},"100541124","radical-hypofractionated-radiotherapy-for-localized-prostate-cancer-100541124","NCT06325774","Radical Hypofractionated Radiotherapy for Localized Prostate Cancer","Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial","Inclusion Criteria:\n\n* Age: ≥18 years old;\n* European Cooperative Oncology Group score(ECOG):≤ 2;\n* Patients with pathologically diagnosed prostate cancer;\n* Clinical stage was cTanyN0M0 any Gleason \u002F ISUP group;\n* Expected survival time \\>5 years;\n* The patient has no contraindications to radiotherapy and is suitable and willing to undergo radiotherapy;\n* Patients who voluntarily accept the experimental study protocol after being informed about the existing treatment options;\n\nExclusion Criteria:\n\n* Patients who have received any other early treatment for prostate cancer, including radiotherapy, chemotherapy, focal therapy, etc;\n* a previous history of pelvic and abdominal radiotherapy;\n* Prior hormonal therapy (castration or antiandrogen);\n* Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and\u002For positive syphilis;\n* Patients that the investigator considers unsuitable to participate in the clinical trial; patients with other serious systemic diseases, evaluation and compliance of the trial, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary, and other systemic diseases;\n* Patients with contraindications related to radiotherapy;\n* Participate in other clinical trials that are mutually exclusive with the study intervention within 4 weeks prior to the start of the study;\n* Patients unable to provide written informed consent or demonstrate poor treatment compliance",{"count":310,"type":21},20,[57],"The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.\n\nHypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.\n\nAccumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.",[26],{"date":295,"type":36},{"date":316,"type":21},"2024-09-01",{"date":318,"type":21},"2031-09-01",{"name":301,"class":109},{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":17,"minAge":328,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":331,"conditions":332,"keywords":333,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":44},"100543953","clinical-study-of-hifu-for-localized-prostate-cancer-100543953","NCT06362577","Clinical Study of HIFU for Localized Prostate Cancer","Post-marketing Clinical Study of Transrectal High-intensity Focused Ultrasound for Localized Prostate Cancer","HIFU","Inclusion Criteria:\n\n1. Men over the age of Forty;\n2. Localized prostate cancer for which transperineal template prostate biopsy or MRI targeted biopsy combined with systematic biopsy is performed;\n3. Ti-T2cN0M0 disease stage; Serum psa \\< 20 ng\u002Fml; Gleason score ≤7(3+4 or 4+3 or lower); Or the researcher evaluates the medium-low risk prostate cancer within T2 stage without lymph node and distant metastasis; Treatment was performed using Sonablate® transrectal high intensity focused ultrasound (HIFU) or robot-assisted laparoscopic radical prostatectomy (RALP)\n\nExclusion Criteria:\n\n* Either must be \\"No\\" or the patient cannot be enrolled.\n\n  1. The active stage accompanied by other genitourinary system infections 100 days before surgery;\n  2. Men who have previously received radiation therapy;\n  3. Laboratory-assessed abnormalities of renal function in the heart and liver prior to surgical treatment: ALT, AST, or serum alkaline phosphatase levels above the upper limit of 3-fold normal, coagulation disorders, other malignancies (history of other malignancies other than basal cell carcinoma or squamous skin carcinoma. Patients with a pre-operative history of malignancy that has not recurred in the last 5 years (superficial bladder cancer normally clears in 2 years) are permitted;\n  4. The presence of a metal implant\u002Fstent in the urethra;\n  5. Patients whose lesions were located at the anterior tip of the prostate and in front of the urethra, and other locations where the focus could not be reached or the acoustic channels were blocked by important organs;\n  6. Those who were considered by the investigator to be unsuitable to participate in this clinical trial (such as patients with mental or emotional problems, patients with hearing, speaking, reading, and writing disorders, and poor compliance).","40 Years",{"count":330,"type":21},60,"In this study, the safety and effectiveness data of Sonablate system, a transrectal high-intensity focused ultrasound therapeutic instrument, in the treatment of localized prostate cancer were collected, and the treatment conditions of patients with other methods (such as radical prostatectomy) were compared and analyzed. Observe the differences in treatment effect, survival rate, postoperative PSA, recurrence and complications.\n\nTo analyze and compare the clinical outcome, postoperative complications and tumor control of HIFU and robot-assisted laparoscopic radical prostatectomy for localized prostate cancer, and to explore the effectiveness and safety of HIFU in the treatment of localized prostate cancer, so as to provide an alternative treatment for localized prostate cancer.",[26],[326,334],"Localized prostate cancer","2024-08-13",{"date":337,"type":36},"2024-08-15",{"date":339,"type":36},"2024-05-21",{"date":341,"type":21},"2026-12-31",{"name":343,"class":109},"RenJi Hospital",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":351,"enrollmentInfo":352,"targetDuration":4,"studyType":55,"phases":354,"briefSummary":355,"conditions":356,"keywords":357,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":44},"100440057","phase-2-functional-image-guided-carbon-ion-irradiation-with-simultaneous-integrated-boost-for-prostate-cancer-100440057","NCT05010343","Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer","Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Pathologically confirmed adenocarcinoma of prostate\n* Stage cT1-3N0M0 localized prostate cancer\n* performed PSMA PET\u002FCT and mpMRI before treatment\n* No lymph nodes or distant metastasis\n* Age ≥ 45 and \\\u003C 85 years of age\n* Karnofsky Performance Score ≥70\n* No previous pelvic radiation therapy (RT)\n* No previous prostatectomy\n* No previous invasive cancer (within 5 years before the prostate cancer diagnosis)\n* Ability to understand character and individual consequences of the clinical trial\n* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial\n\nExclusion Criteria:\n\n* No pathologically confirmed adenocarcinoma of the prostate\n* Pelvic lymph node metastasis (N1)\n* Distant metastasis (M1)\n* Previous pelvic radiotherapy\n* Previous prostatectomy","85 Years",{"count":353,"type":21},140,[121],"This is a phase II randomized controlled clinical trial to assess the toxicities and clinical efficacy of prostate specific membrane antigen (PSMA) positron emission tomography \u002F computed tomography (PET\u002FCT) and multi- parameter Magnetic Resonance Imaging (MRI) guided simultaneous integrated boost for prostate cancer.",[26],[358,359,360,361],"carbon ion irradiation","Simultaneous Integrated Boost","PSMA PET\u002FCT","mpMRI","2021-11-12",{"date":364,"type":36},"2021-11-15",{"date":366,"type":36},"2020-10-15",{"date":368,"type":21},"2028-07-01",{"name":370,"class":109},"Shanghai Proton and Heavy Ion Center"]