[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundacion Oncosur\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100560859","phase-2-talazoparib-plus-enzalutamide-after-progression-to-abiraterone-in-metastatic-prostate-cancer-team-pc-100560859",false,"NCT06582628","Talazoparib Plus Enzalutamide After Progression to Prior ARPi in Metastatic Prostate Cancer","A Multicenter, Open Label, Randomized Phase II Trial to Evaluate the Efficacy of Talazoparib Plus Enzalutamide as First Line Treatment for Patients With Metastatic Castration Resistant Prostate Cancer After Progression to an Androgen Receptor Pathway Inhibitor","TEAM PC","Inclusion Criteria:\n\n1. Male age 18 or older.\n2. Histological diagnosis of prostate adenocarcinoma without neuroendocrine differentiation or small cell features.\n3. Willing and able to provide written informed consent to participate in the study. Written consent must be given before registration, according to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) \u002F Good clinical practice (GCP), and national\u002Flocal regulations.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n5. Willing to provide tumor biopsies during the study. Note: At study entry, the pre-treatment new tumor biopsy (fresh-frozen and Formalin-fixed and paraffin-embedded (FFPE) material) could be replaced by an archived tumor biopsy upon agreement from the study chief investigator if such biopsy has been taken after progression to metastatic castration resistance and has both archived fresh-frozen material and a FFPE block with a minimum tumor content over 30 percent. Still the patient must be amenable and willing to undergo a new mandatory post-treatment biopsy.\n6. Willing to provide blood samples for biomarker analysis.\n7. Willing to give consent to sequencing of DNA damage repair (DDR) genes for analysis of the prevalence of somatic and germline aberrations in DNA damage repair genes.\n8. Metastatic (M1) prostate cancer documented by bone scan, or soft tissue disease documented by computed tomography (CT), or magnetic resonance imaging (MRI).\n9. Asymptomatic or minimally symptomatic prostate cancer at screening.\n10. Estimated life expectancy of greater than or equal to 6 months from screening.\n11. Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist or antagonist for participants who have not undergone bilateral orchiectomy must be in place before screening and must continue throughout the study.\n\n12 .Disease progression after at least 12 weeks of treatment with a prior androgen-receptor signalling inhibitor (ARPi), including abiraterone acetate or a direct AR inhibitor, such as enzalutamide, apalutamide, or darolutamide, for metastatic hormone-sensitive prostate cancer. Note: Patients who previously received Enzalutamide can be recruited but up to a maximum of 6. Those patients will be included directly into the experimental arm. Progression is defined as:\n\na. PSA rise of greater than or equal to 25 percent and an absolute increase of greater than or equal to 2 ng\u002FmL above nadir (or baseline for participants with no PSA decline), confirmed by a second PSA value at least 3 weeks later.\n\nand \u002F or b. Limited radiographic progression: maximum of 2 new bone metastases, no new soft tissue metastasis and less than 50 percent increase in the size of measurable soft tissue lesions.\n\n13\\. Participants who have received prior docetaxel must meet the following criteria:\n\na. Received a maximum of 6 cycles of docetaxel for mHSPC and b. Received the last dose of docetaxel equal or higher than 6 months prior to randomization.\n\n14\\. Participants who have received prior Lu177-PSMA must meet the following criteria:\n\na. Received a maximum of 6 cycles of docetaxel for mHSPC. b. Received the last dose of Lu177-PSMA equal or higher than 6 months prior to randomization 15. Adequate organ function within 28 days before the first study treatment on Day 1, defined by the following:\n\n1. Haemoglobin greater than or equal to 10 g\u002FdL, no blood transfusions within 14 days before obtaining the haematology laboratory tests at screening,\n2. Platelets greater than or equal to 100,000\u002FμL no platelets transfusions within 14 days before obtaining the haematology laboratory tests at screening,\n3. Neutrophils greater than or equal to 1500\u002FμL, no growth factors given within 14 days before obtaining the haematology laboratory tests at screening,\n4. Serum creatinine less than1.5X ULN or calculated creatinine clearance greater than or equal to 50 mL\u002Fmin\n5. Albumin greater than 3 g\u002FdL,\n6. AST or ALT less than 2.5 × ULN (less than 5 × ULN if liver function abnormalities are due to hepatic metastasis).\n7. Total serum bilirubin less than 1.5 × ULN (less than 3 × ULN for participants with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation). 16. Ability to swallow study medication tablets and comply with study requirements.\n\n   17\\. Agrees to use a condom and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant, starting contraception at screening and continue throughout the study period and for 3 months after the final treatment administration, (during the treatment period and for at least 90 days after last dose of enzalutamide or at least 120 days after las dose of talazoparib, whichever occurs later) unless the patient is unable to maintain intercourse due to the androgen deprivation.\n\n   18\\. Subjects must not donate sperm starting at screening and throughout the study period and for 3 months after the final abiraterone acetate administration.\n\n   19\\. Subject agrees not to participate in another interventional study while with experimental medical products or anticancer drugs not approved in this setting on treatment in this study. Exceptions could be allowed for protocols investigating the survival or quality of life impact of common routine or conventional drugs (i.e. acetylsalicylic acid, statins, oral antidiabetic drugs) as long as they do not intefere with the study treatment and the evaluation of the main study arms.\n\n   20\\. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Prior ARPi treatment for less than 12 weeks or disease progression (either PSA or radiographic progression) within 6 months of starting abiraterone or ARi.\n2. Known or suspected brain metastasis or active leptomeningeal disease.\n3. Symptomatic or impending spinal cord compression or cauda equina syndrome.\n4. Use of opiate analgesia for pain from prostate cancer with average Brief pain inventory (BPI) questionnaire score higher than or equal to 6 and\u002For uncontrolled prostate cancer-related pain requiring increasing doses of opiates within 4 weeks prior to randomization\n5. Prior treatment with more than one ARPi. This will include abiraterone, enzalutamide, apalutamide, or darolutamide, which are treatments with demonstrated PFS and\u002For OS benefit in mHPSC, as well as any other novel AR or androgen synthesis directed therapy (with the exception on LHRH\u002FGnRH analogues and\u002For antagonists). Note: Patients who started on one ARPi and switched to another due to toxicity will only be eligible after prior discussion with the study chair, provided that they were on the first ARPi (other than enzalutamide) for a very limited period of time and can document that they were responding - without PSA rise or worsening symptoms - at the moment they were switched to the second ARPi. Inclusion of such cases will require written notification and approval from the study chair or co-chair.\n6. Therapeutic radiation therapy within, 14 days (7 days for limited-field palliative radiotherapy) prior to study enrolment, or participants who have not recovered from radiotherapy-related toxicities to grade less than or equal to 1 according to NCI-CTCAE v.5.0.\n7. Major surgery within 4 weeks prior to randomization or participants who have not recovered from the side effects of any major surgery.\n8. Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 30 days of Cycle 1 Day 1 or currently enrolled in an investigational study.\n9. History of seizure or any condition that may predispose to seizure (i.e., prior significant brain trauma, brain vascular malformation, etc) or subjects that have had an unexplained loss of consciousness or transient ischemic attacks within 1 year previous to scheduled day 1 of treatment.\n10. Congenital long QT syndrome or ECG at screening with QT interval corrected using Fridericia's formula (QTcF) greater than 500 milliseconds.\n11. Participants with clinically significant cardiovascular disease including but not limited to any of the following:\n\n    1. Stroke, transient ischemic attack, unstable angina pectoris or documented myocardial infarction within 12 months prior to study entry.\n    2. Symptomatic pericarditis or clinically significant pericardial effusion or myocarditis\n    3. Documented congestive heart failure (New York Heart Association Class, NYHA functional classification III-IV)\n    4. Uncontrolled, persistent hypertension defined as systolic blood pressure greater than 170mmHg or diastolic blood pressure greater than100mmHg. Subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment\n12. Participants with any of the following cardiac conduction abnormalities:\n\n    1. Ventricular arrhythmias except for benign premature ventricular contractions\n    2. Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication.\n    3. Conduction abnormality requiring a pacemaker.\n    4. Other cardiac arrhythmia not controlled with medication.\n13. Any clinically significant gastrointestinal disorder affecting absorption (i.e., extensive small bowel resection, active inflammatory bowel disease).\n14. Active or symptomatic viral hepatitis or chronic liver disease.\n15. Known\u002Fpossible hypersensitivity, allergies to enzalutamide, talazoparib or any of capsule excipients.\n16. Other malignancy except:\n\n    1. Carcinoma in situ or non-melanoma skin cancer.\n    2. A cancer diagnosed and treated greater than or equal to 5 years before randomization with no subsequent evidence of recurrence.\n17. Any condition or situation which, in the opinion of the investigator, would put the subject at risk, may confound study results, or interfere with the subject's participation in this study.","MALE","18 Years",{"count":20,"type":21},78,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this clinical trial is to determine the anti-tumor activity of talazoparib plus enzalutamide as first line treatment for metastatic castration resistant prostate cancer (mCRPC) in participants whose disease has progressed on Androgen Receptor Pathway Inhibitor (ARPI).\n\nThe main questions it aims to answer are:\n\n* Does talazoparib plus enzalutamide improve efficacy in metastatic castration resistant prostate cancer (mCRPC) compared to enzalutamide alone?\n* What is the time to disease progression \\[radiographic, Prostate Specific Antigen (PSA), clinical\\] in participants treated with talazoparib plus enzalutamide after progression on abiraterone?\n* What medical problems do participants have when receiving talazoparib plus enzalutamide?\n\nResearchers will compare the combination of talazoparib and enzalutamide as a first-line treatment for mCRPC to see if the combination improves the PSA response rate and delays progression compared to enzalutamide alone. The safety and tolerability of the combination (talazoparib and enzalutamide) will also be studied",[27],"Metastatic Prostate Cancer",[29,30,31,32,33,34,35,36],"Prostatic Diseases","Prostatic Cancer","metastatic castration resistant prostate cancer (mCRPC)","prostate adenocarcinoma","metastatic hormone-sensitive prostate cancer","Poly (ADP-ribose) Polymerases (PARP)","Prostate Specific Antigen","Abiraterone","RECRUITING","2026-09-30",{"date":40,"type":41},"2026-10-05","ACTUAL",{"date":43,"type":41},"2024-07-05",{"date":45,"type":21},"2029-02-28",{"name":47,"class":48},"Fundacion Oncosur","NETWORK",19,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100482555","phase-2-pembrolizumab-carboplatin-and-cabazitaxel-in-aggressive-metastatic-castration-resistant-prostate-cancer-peapodfos-100482555","NCT05563558","Pembrolizumab, Carboplatin and Cabazitaxel in Aggressive Metastatic Castration Resistant Prostate Cancer (PEAPOD_FOS)","A Phase 2 Clinical Trial of Pembrolizumab in Combination With Carboplatin and Cabazitaxel in Aggressive Variant Metastatic Castration Resistant Prostate Cancer","PEAPOD_FOS","Inclusion Criteria:\n\n* Male participants who are at least 18 years of age on the day of signing informed consent\n* Histologically confirmed diagnosis of adenocarcinoma and\u002For neuroendocrine carcinoma of the prostate will be enrolled in this study\n* Presence of metastatic disease documented on imaging studies (bone scan, computed tomography (CT) and\u002For magnetic resonance imaging (MRI) scans\n* At least one of the following Aggressive Variant Prostate Cancer (AVPC) Criteria\n\n  1. Histologically proven small cell (neuroendocrine) prostate cancer\n  2. Exclusive visceral metastases\n  3. Predominantly lytic bone metastases\n  4. Bulky lymph nodes (≥ 5 cm in longest dimension) or high-grade pelvic\u002Fprostatic masses\n  5. Low PSA (≤10 ng\u002Fml) at initial presentation in the presence of extensive disease (≥20 metastases)\n  6. Elevated serum Lactate Dehydrogenase (LDH) (≥2 x ULN) or carcinoembryonic antigen (CEA) (≥2 x Upper limit (UL))\n  7. Short time to castration-resistance (≤6 months).\n* Male participants: a male participant must agree to use a contraception as detailed in Appendix 3 of the protocol during the treatment period and for at least after the last dose of study treatment and refrain from donating sperm during this period\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Have provided archival tumor tissue sample obtained in the previous year since or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n* Have adequate organ function as defined in the table 1 of the protocol. Specimens must be collected within 10 days prior to the start of study intervention.\n* Criteria for known Hepatitis B (HBV) and C (HCV) positive subjects\n\n  1. Hepatitis B and C screening tests are not required unless:\n\n     * Known history of HBV or HCV infection\n     * As mandated by local health authority\n  2. Hepatitis B positive subjects\n\n     * Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n     * Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n  3. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. • Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\nExclusion Criteria:\n\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4), OX-40, CD137).\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to informed consent signature.\n* Has received previous treatment with cabazitaxel or carboplatin.\n* Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (non-CNS) disease.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab, carboplatin or cabazitaxel and\u002For any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an active infection requiring systemic therapy\n* Has congestive Heart failure New York Heart Association (NYHA) ≥2.\n* Has hypoacusis grade ≥2.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection\n* Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n\nNote: Hepatitis B and C screening tests are not required unless:\n\n* Known history of HBV and HCV infection\n* As mandated by local health authority\n\n  * Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n  * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n  * Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":59,"type":21},42,[24],"It is a Phase 2 clinical trial of Pembrolizumab in combination with Carboplatin and Cabazitaxel in Aggressive Variant Metastatic Castration Resistant Prostate Cancer.\n\nIt is divided into two parts: an induction period of 6 cycles of 3 weeks each cycle of Pembrolizumab+Cabazitaxel+Carboplatino and a maintenance phase of 15 cycles of 6 weeks each cycle of Pembrolizumab.",[63],"Prostate Cancer Metastatic","2024-06-10",{"date":66,"type":41},"2024-06-11",{"date":68,"type":41},"2023-05-05",{"date":70,"type":21},"2026-11-01",{"name":47,"class":48},1,""]