[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostatic-neoplasms-castration-resistant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostatic-neoplasms-castration-resistant":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,45,67,83,138,162,184,207,238,264,287,325,359],{"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":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100053259","pluvicto-real-world-investigation-in-survival-in-metastatic-crpc-100053259",false,"NCT07697989","Pluvicto Real-world Investigation in Survival in Metastatic CRPC","Real World Clinical Effectiveness of [177Lu]Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients: A Non-Interventional Study","PRISM","Inclusion criteria:\n\n1. Patients with at least one inpatient OR two outpatient primary prostate cancer (PC) diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification \\[ICD-10-CM\\]: C61) during the identification period. For outpatient diagnoses, the second confirmatory PC diagnosis must be at least 30 to 365 days after the first primary diagnosis date.\n2. Patients with a metastatic diagnosis (ICD-10-CM: C77-C79) on or after the primary PC diagnosis date. The earliest metastatic diagnosis will be the patient's metastatic diagnosis date.\n3. Patients with an mCRPC diagnosis on or after the metastatic diagnosis or satisfying any of the proxy criteria.\n4. Patients with evidence of treatment with \\[177Lu\\]Lu-PSMA-617 after the mCRPC diagnosis date. The date of \\[177Lu\\]Lu-PSMA-617 administration will be considered as the index date.\n5. Patients ≥18 years of age on metastatic diagnosis date.\n6. Patients who are male.\n7. Patients with at least 12 months pre-index and at least six months post-index (unless patient died) of medical history or continuous medical and pharmacy enrollment or activity (three-month allowable gap).\n\nExclusion criteria:\n\n1. Patients with other non-prostate primary cancer (≥ two ICD codes for one specific type of cancer in the baseline period at least 30 days apart) within three years prior to the first PC diagnosis.\n2. Patients enrolled in a current clinical trial\u002Finvestigational study within the 30-day period immediately prior to and including the index date or within five half-lives of the investigational product (whichever is longer) or during post-index period (ICD-10-CM: Z00.6).\n3. Patients with missing age and gender information.","MALE","18 Years",{"count":20,"type":21},1085,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the various aspects of treatment effectiveness of \\[177Lu\\]Lu-PSMA-617 (Pluvicto) in mCRPC patients in both pre- and post-taxane settings. The study will be conducted using real-world data sources from the United States (US) and Germany.",[25,26],"Prostatic Neoplasms, Castration-Resistant","Neoplasm Metastasis",[28,29,30,31,32],"Pluvicto","177Lu-PSMA-617","Metastatic Castration Resistant Prostate Cancer","Effectiveness","Survival","NOT_YET_RECRUITING","2026-07-06",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":21},"2026-06-30",{"date":41,"type":21},"2026-10-31",{"name":43,"class":44},"Novartis Pharmaceuticals","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100644918","a-study-of-real-world-characteristics-treatment-patterns-and-outcomes-among-mcrpc-patients-previously-treated-with-an-androgen-receptor-pathway-inhibitor-taxane-based-chemotherapy-and-lutetium-177-vipivotide-tetraxetan-100644918","NCT07677267","A Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan","Real-World Characteristics, Treatment Patterns, and Outcomes Among Adults With mCRPC Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan","Inclusion criteria:\n\n* Evidence of 177Lu-PSMA-617 use on or after 01 January 2021.\n* Evidence of treatment with ≥1 ARPI, before 177Lu-PSMA-617.\n* Evidence of treatment with ≥1 taxane, before or after 177Lu-PSMA-617.\n* Diagnosis of mCRPC prior to or on the index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.\n* Age ≥18 years at index.\n\nExclusion criteria:\n\n• None.","115 Years",{"count":54,"type":21},1067,"The aim of this study is to assess treatment patterns, characteristics, and clinical outcomes among adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously received ≥1 androgen receptor pathway inhibitor (ARPI), ≥1 taxane, and 177Lu-PSMA-617 in the United States (US) real-world clinical practice. This study will be conducted using data extracted from the PRECISION (PRostatE Cancer dISease observatION) data platform.",[25],[58,59,60],"Metastatic Castration-Resistant Prostate Cancer","Androgen Pathway Modulation-Resistant","APMR","2026-06-24",{"date":39,"type":37},{"date":39,"type":21},{"date":65,"type":21},"2026-11-30",{"name":43,"class":44},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":81,"leadSponsor":82,"locationsCount":4},"100644849","a-study-of-real-world-characteristics-treatment-patterns-and-clinical-outcomes-in-patients-with-metastatic-castration-resistant-prostate-cancer-100644849","NCT07677254","A Study of Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer","Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Contemporary Patients With Metastatic Castration-Resistant Prostate Cancer in the PRECISION Data Platform","Inclusion criteria:\n\n* Diagnosis of mCRPC between 01 January 2021 and 31 December 2025.\n* Male sex at index, where index is the date of initial mCRPC diagnosis.\n* Age 18 years at index.\n\nExclusion criteria:\n\n• None",{"count":75,"type":21},17111,"The aim of this study is to assess treatment patterns, clinical outcomes, and patient characteristics among adults with metastatic castration-resistant prostate cancer (mCRPC) in the United States (US) real-world clinical practice. This study will be conducted using data extracted from the PRECISION (PRostatE Cancer dISease observatION) data platform.",[25],[58,59,60],{"date":39,"type":37},{"date":39,"type":21},{"date":65,"type":21},{"name":43,"class":44},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":90,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":93,"phases":94,"briefSummary":97,"conditions":98,"keywords":106,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},"100370548","phase-1-a-study-of-tulmimetostat-dzr123-cpi-0209-in-patients-with-advanced-solid-tumors-and-lymphomas-100370548","NCT04104776","A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","A Phase 1\u002F2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","Key Inclusion Criteria:\n\nAll Patients:\n\n* Adults aged ≥18 years with life expectancy ≥12 weeks\n* ECOG performance status 0-1\n* Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions)\n* Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds\n* Willingness to provide tumor tissue and blood samples for biomarker analyses\n* Agreement to protocol-specified contraception requirements\n* Signed informed consent prior to study procedures\n\nDisease-Specific Inclusion Criteria:\n\nPhase 1 (Dose Escalation):\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumors or lymphoma\n* Disease refractory to standard therapy or with no available effective standard treatment\n* For prostate cancer: castrate testosterone levels maintained throughout the study\n\nPhase 2 (Disease-Specific Cohorts):\n\n* M1: ARID1A mutant urothelial carcinoma or other ARID1A mutant solid tumors (with cohort specific prior therapy and RECIST 1.1 measurable disease requirements)\n* M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless contraindicated)\n* M3: ARID1A mutant recurrent\u002Fmetastatic endometrial carcinoma after platinum therapy and appropriate immunotherapy\n* M4: Relapsed\u002Frefractory peripheral T cell lymphoma or diffuse large B cell lymphoma, transplant-ineligible, with measurable disease\n* M5: Relapsed\u002Frefractory pleural or peritoneal mesothelioma with documented BAP1 loss\n* M6: Metastatic castration-resistant prostate cancer (mCRPC) with documented progression after AR targeted therapy and taxane chemotherapy\n* M7: ARID1A wild type endometrial carcinoma (exploratory food-effect cohort)\n* M8: mCRPC treated with DZR123 in combination with enzalutamide, with cohort specific requirements for prior androgen receptor pathway inhibitor and chemotherapy exposure\n\nKey Exclusion Criteria:\n\nAll Patients:\n\nMedical Conditions:\n\n* Prior solid organ or allogeneic hematopoietic cell transplant\n* Active or untreated symptomatic CNS metastases (with limited exceptions)\n* Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc\n* Active interstitial lung disease or pneumonitis\n* Uncontrolled infections or significant gastrointestinal disorders affecting absorption\n* Active HIV or hepatitis B\u002FC infection\n* Concurrent malignancy requiring active treatment (with protocol-defined exceptions)\n* Pregnancy, breastfeeding, or inability to comply with protocol requirements\n\nPrior or Concomitant Therapy:\n\n* Recent anticancer therapy within protocol-defined washout periods\n* Prior EZH2 inhibitor treatment\n* Recent radiation or liver-directed therapies outside allowed windows\n* Use of strong CYP3A4\u002F5 inhibitors or inducers\n\nAdditional Cohort-Specific Exclusions:\n\n* M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies\n* M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease","ALL",{"count":92,"type":21},275,"INTERVENTIONAL",[95,96],"PHASE1","PHASE2","The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.",[99,100,101,102,25,103,104,105],"Advanced Solid Tumor","Diffuse Large B Cell Lymphoma","Lymphoma, T-Cell","Mesothelioma, Malignant","Endometrial Cancer","Ovarian Clear Cell Carcinoma","Metastatic Castration-resistant Prostate Cancer",[107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,103,104,124,125,126,127],"Tulmimetostat","DZR123","Lymphoma, Large B-Cell, Diffuse","Lymphoma, B-cell","Lymphoma, T-cell","Lymphoma, Non-Hodgkin","Lymphoma","Neoplasms by Site","Neoplasms by Histologic Type","Neoplasms","Lymphoproliferative Disorders","Lymphatic Diseases","Immunoproliferative Disorders","Immune System Diseases","Topoisomerase Inhibitors","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents","Food effect","Adenine-thymine (AT)-rich interactive domain-containing protein 1A (ARID1A)","ARID1A wildtype (ARID1A WT) endometrial carcinoma","Metastatic castration-resistant prostate cancer (mCRPC)","RECRUITING","2026-06-17",{"date":131,"type":37},"2026-06-22",{"date":133,"type":37},"2019-09-18",{"date":135,"type":21},"2030-02-27",{"name":43,"class":44},81,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":90,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":93,"phases":148,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100610312","phase-3-a-study-of-pasritamig-with-docetaxel-versus-docetaxel-in-participants-with-metastatic-castration-resistant-prostate-cancer-100610312","NCT07225946","A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer","A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer","KLK2-PASenger","Inclusion criteria:\n\n* Have histologically confirmed adenocarcinoma of the prostate\n* Have disease that is metastatic at the time of the screening as determined by the investigator\n* Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog throughout the treatment or have had prior bilateral orchiectomy, and have serum testosterone less than or equal to (\\\u003C=) 50 nanogram per milliliter (ng\u002FdL) (\\\u003C= 1.73 nanomoles per Liter \\[nmol\u002FL\\]) at screening\n* Have progressed on at least 1 novel androgen receptor pathway inhibition (ARPI) but received no more than 2 different ARPI for any stage of disease. Must have discontinued ARPI before randomization into the study\n* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1\n\nExclusion criteria:\n\n* Known history of either brain or leptomeningeal prostate cancer metastases\n* Participants with known breast cancer gene 1\u002F2 (BRCA 1\u002F2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated\n* Prior or concurrent second malignancy (other than the disease under study) because the natural history or treatment could interfere with study endpoints\n* Received cytotoxic chemotherapy for prostate cancer in any setting\n* Received prior treatment with human kallikrein 2 (KLK-2) directed therapies",{"count":147,"type":21},800,[149],"PHASE3","The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).",[25],"2026-06-04",{"date":154,"type":37},"2026-06-05",{"date":156,"type":37},"2025-12-19",{"date":158,"type":21},"2029-07-20",{"name":160,"class":44},"Janssen Research & Development, LLC",136,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":90,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":93,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},"100543247","phase-1-substudy-01a-safety-and-efficacy-of-opevesostat-mk-5684-based-treatment-combinations-or-opevesostat-alone-in-participants-with-metastatic-castration-resistant-prostate-cancer-mcrpc-mk-5684-01a-100543247","NCT06353386","Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)","MK-5684-01A Substudy: A Phase 1\u002F2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology.\n* Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening.\n* Evidence of disease progression from either, \\>4 weeks from last flutamide treatment, or \\>6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy.\n* Current evidence of metastatic disease.\n* Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment.\n* Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for \\>4 weeks before randomization.\n* Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to \\\u003CGrade 1 or baseline.\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.\n* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load.\n* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* History of pituitary dysfunction.\n* Poorly controlled diabetes mellitus.\n* Active or unstable cardio\u002Fcerebro-vascular disease, including thromboembolic events and history of stroke or transient ischemic attack within 6 months before the first dose of study intervention, history of myocardial infarction within 6 months before the first dose of study intervention, New York Heart Association Class III or IV cardiac disease or congestive heart failure, coronary heart disease that is symptomatic, or unstable angina\n* History or family history of long corrected QT interval (QTc) syndrome.\n* Myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or features suggestive of MDS\u002FAML.\n* History or current condition of adrenal insufficiency.\n* History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and\u002For complications.\n* Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention.\n* Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization).\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n* Received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities, requiring corticosteroids.\n* Received a live or live-attenuated vaccine within 30 days before the first does of study intervention. Administration of killed vaccines is allowed.\n* Diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy, or any other form of immunosuppressive therapy, within 7 days prior to the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Active autoimmune disease that has required systemic treatment in the past 2 years.\n* Active infection requiring systemic therapy.\n* Concurrent active HBV or HCV infections.",{"count":170,"type":21},220,[95,96],"Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01).\n\nThe goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.\n\nThis substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.",[25],"2026-05-21",{"date":176,"type":37},"2026-05-26",{"date":178,"type":37},"2024-05-20",{"date":180,"type":21},"2029-01-15",{"name":182,"class":44},"Merck Sharp & Dohme LLC",77,{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":93,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100429171","phase-1-64cu-sar-bispsma-and-67cu-sar-bispsma-for-identification-and-treatment-of-psma-expressing-metastatic-castrate-resistant-prostate-cancer-secure-100429171","NCT04868604","64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)","A Phase I\u002FIIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer","SECuRE","Inclusion Criteria:\n\n* Signed informed consent;\n* ≥18 years of age;\n* Eastern Cooperative Oncology Group performance status of 0 to 2;\n* Life expectancy \\>6 months;\n* Histological, pathological, and\u002For cytological confirmation of Prostate cancer (PCa);\n* Positive 64Cu-SAR-bisPSMA PET\u002FCT scan, where 64Cu-SAR-bisPSMA uptake (standardized uptake value \\[SUV\\] max) of at least 1 known lesion is higher than that of the liver on the 1 hour positron emission tomography (PET)\u002Fcomputed tomography (CT) scan;\n* Castrate level of serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL);\n* Have progressive metastatic castration-resistant prostate cancer (mCRPC) despite prior androgen deprivation therapy and:\n\n  * Dose Escalation: at least either enzalutamide and\u002For abiraterone (or other such androgen receptor pathway inhibitors \\[androgen receptor pathway inhibitorsARPIs\\]).\n  * Cohort Expansion Main Group: Participant has progressed once or twice on a prior second generation ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide). No concomitant ARPI on study. Note: First generation ARPI is allowed but not considered as prior ARPI. Second generation ARPI must be the most recent therapy received.\n  * Cohort Expansion Concomitant Enzalutamide Group: Participant has progressed only once on prior second generation ARPI (prior abiraterone, darolutamide, or apalutamide is allowed, prior treatment with enzalutamide is not allowed). Note: First generation ARPI is allowed but not considered as prior ARPI. Second generation ARPI must be the most recent therapy received.\n\nDocumented progressive mCRPC will be based on at least 1 of the following criteria:\n\n1. Serum\u002Fplasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng\u002FmL;\n2. Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions;\n3. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan.\n\n   * ≥1 metastatic lesion that is present at screening CT, magnetic resonance imaging (MRI), or bone scan imaging obtained ≤28 days prior to enrollment into the study;\n   * Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy, etc.);\n   * Participants must have adequate organ function:\n\n     * Bone marrow reserve:\n\n       * White blood cell (WBC) count ≥2.5 x 109\u002FL (2.5 x 109\u002FL is equivalent to 2.5 x 103\u002FμL and 2.5 x K\u002FμL and 2.5 x 103\u002Fcc and 2500\u002FμL) OR\n       * Absolute neutrophil count (ANC) ≥1.5 x 109 \u002FL (1.5 x 109 \u002FL is equivalent to 1.5 x 103 \u002FμL and 1.5 x K\u002FμL and 1.5 x 103 \u002Fcc and 1500\u002FμL);\n     * Platelets ≥100 x 109 \u002FL (100 x 109 \u002FL is equivalent to 100 x 103 \u002FμL and 100 x K\u002FμL and 100 x 103 \u002Fcc and 100,000\u002FμL);\n     * Hemoglobin ≥9 g\u002FdL (5.59 mmol\u002FL);\n     * Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted;\n     * Alanine aminotransferase or aspartate aminotransferase ≤3.0 x ULN OR ≤5.0 x ULN for participants with liver metastases;\n     * Creatinine clearance or estimated glomerular filtration rate ≥50 mL\u002Fmin\n   * For participants who are human immunodeficiency virus infected: Participant must be healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes in the opinion of the Investigator;\n   * For participants who have partners of childbearing potential: Partner and\u002For participant must use a method of birth control with adequate barrier protection.\n\nExclusion Criteria:\n\n* Major surgery within 12 weeks prior to enrollment into the study;\n* Brain metastasis;\n* Histologic diagnosis of small cell or neuroendocrine prostate cancer;\n* Prior history of leukemia or Myelodysplastic Syndrome;\n* Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study;\n* Unmanageable urinary tract obstruction;\n* Evidence of progressive lesion(s) on MRI and\u002For CT (according to Response Evaluation Criteria in Solid Tumors V1.1) that is prostate-specific membrane antigen (PSMA) negative on the 1 hour 64Cu-SAR-bisPSMA PET\u002FCT scan as determined at screening. NOTE: THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE 64Cu-SAR-bisPSMA DOSIMETRY PHASE AND DOSE ESCALATION PHASE.\n* Previous treatment with a systemic radionuclide:\n\n  * Dose Escalation: Previous treatment with a systemic radionuclide, including 177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor;\n  * Cohort Expansion: Previous treatment with a systemic radionuclide, including Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor; Any previous PSMA targeted radionuclide therapy (including 177Lu and Actinium-225) is also excluded.\n* Previous treatment with any systemic anti-cancer therapy (e.g. immunotherapy or biological therapy \\[including monoclonal antibodies\\]) within 4 weeks prior to treatment on study with the exception of Luteinizing Hormone Releasing Hormone (LHRH), any other androgen deprivation therapy (ADT) or low dose corticosteroids.\n\n  * Dose Escalation: prior treatment with chemotherapy within 4 weeks of first administration of 67Cu-SAR-bisPSMA is also excluded.\n  * Cohort Expansion: Prior treatment with cytotoxic chemotherapy for castration resistant PCa (e.g. taxanes, platinum, estramustine, vincristine, methotrexate, etc) is also excluded. Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with any poly (adenosine diphosphate-ribose) polymerase inhibitors (PARPi) is also excluded. NOTE: THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE 64Cu-SAR-bisPSMA DOSIMETRY PHASE;\n* Previous treatment with any investigational agents within 4 weeks prior enrollment into the study;\n* Known hypersensitivity to the components of the investigational products or its analogues;\n* Transfusion for the sole purpose of making a participant eligible for study inclusion;\n* Spinal metastasis with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression;\n* Concurrent serious medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation;\n* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;\n* Any condition or personal situation that would pose an unacceptable radiation safety risk (as per institution guidelines, state and\u002For national regulations) to the participant or carer at the time of release following the completion of therapy (e.g. uncontrolled urinary incontinence, high dependency care);\n* Participants in whom it is known that external beam radiation therapy is scheduled after enrollment into the study. NOTE: THIS CRITERION IS NOT APPLICABLE TO PARTICIPANTS IN THE 64Cu-SAR-bisPSMA DOSIMETRY PHASE.\n* Participants in the Cohort Expansion Concomitant Enzalutamide Group:\n\n  1. Participants with known hypersensitivity to enzalutamide or any of its ingredients.\n  2. Participants with a history of seizures.\n  3. Participants with a history of loss of consciousness (unless of cardiac origin) or transient ischemic attack within 12 months prior to enrolment into the study.\n  4. Participants with conditions that increase the risk of seizures include those with a history of traumatic brain injury, stroke or cerebrovascular disease, arteriovenous malformations in the brain, neurodegenerative diseases, primary or metastatic brain tumors, active leptomeningeal disease, uncontrolled hypertension (systolic \\>179 or diastolic \\>105), patients undergoing alcohol withdrawal.",{"count":193,"type":21},54,[95,96],"The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.",[25],"2026-05-04",{"date":199,"type":37},"2026-05-06",{"date":201,"type":37},"2021-08-11",{"date":203,"type":21},"2026-09",{"name":205,"class":44},"Clarity Pharmaceuticals Ltd",7,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":93,"phases":215,"briefSummary":216,"conditions":217,"keywords":223,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":5},"100530754","phase-1-gedatolisib-in-combination-with-darolutamide-in-metastatic-castration-resistant-prostate-cancer-100530754","NCT06190899","Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer","A Phase 1\u002F2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria\n\n1. Adult males ≥18 years of age\n2. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with \\\u003C10% neuroendocrine type cells\n3. Subjects must have metastatic castration-resistant prostate cancer (mCRPC; i.e., developed progression of metastases following surgical castration or during medical androgen ablation therapy)\n4. Metastatic disease identified by conventional imaging: computed tomography (CT), magnetic resonance imaging (MRI), or technetium 99m-methyl diphosphonate (99mTc-MDP) bone scintigraphy. Measurable and non-measurable disease are allowed, but metastases visible only on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) will not be allowed for eligibility purposes.\n5. Progressive mCRPC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working Group 3 (PCWG3) criteria as defined by at least one of the following criteria:\n\n   5.1. Prostate-specific antigen (PSA) progression defined as a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination. A minimum PSA of 1.0 ng\u002FmL is required for study entry.\n\n   5.2. Soft-tissue progression defined as an increase ≥20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. 5.3. Progression of bone disease (measurable disease) or 2 or more new bone lesions by bone scan.\n6. Continued primary androgen deprivation with luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) if the subject has not undergone bilateral orchiectomy\n7. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1\n8. Progression during treatment with one next-generation androgen receptor signaling inhibitor for metastatic disease (e.g., abiraterone, enzalutamide, apalutamide, darolutamide)\n9. Completion of prior treatment with an androgen receptor inhibitor (ARi) ≥4 weeks before the first dose of the study drug\n10. At least 2 weeks beyond treatment with a targeted therapy or major surgery and at least 3 weeks beyond any other systemic anticancer therapy and\u002For radiation therapy, and resolution of all toxicities related to prior therapies or surgical procedures to baseline (except alopecia, Grade 1 peripheral neuropathy)\n11. Adequate bone marrow, hepatic, renal and coagulation function\n\nExclusion Criteria\n\n1. History of malignancies other than adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥3 years\n2. Adenocarcinoma of the prostate with a small cell component, and with ≥10% neuroendocrine type cells\n3. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (AKT) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor\n4. Prior treatment with chemotherapy or radiopharmaceutical therapy for mCRPC (except prior chemotherapy plus ADT for castration-sensitive disease, including docetaxel plus darolutamide).\n5. Subjects with uncontrolled type 1 or type 2 diabetes\n\n9\\. Known and untreated, or active, brain or leptomeningeal metastases. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to randomization 10. History of clinically significant cardiovascular abnormalities 11. Gastrointestinal tract disease resulting in an inability to absorb oral medication as well as history of inflammatory bowel disease 12. Unable to swallow oral medication tablets\u002Fcapsules",{"count":193,"type":21},[95,96],"This is a Phase 1\u002F2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.",[218,219,220,221,25,222],"mCRPC (Metastatic Castration-resistant Prostate Cancer)","Genital Diseases, Male","Urogenital Diseases, Male","Prostatic Disease","Prostate Cancer",[224,225,226,227,228,222,25,221,220,219],"Gedatolisib","PI3K","Protein Kinase Inhibitors","mCRPC (metastatic castration-resistant prostate cancer)","Darolutamide","2026-04-07",{"date":231,"type":37},"2026-04-13",{"date":233,"type":37},"2024-01-01",{"date":235,"type":21},"2030-01",{"name":237,"class":44},"Celcuity Inc",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":246,"conditions":247,"keywords":248,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":263},"100621856","development-and-prospective-validation-of-a-pathology-based-artificial-intelligence-model-for-predicting-the-time-to-castration-resistance-of-prostate-cancer-100621856","NCT07376057","Development and Prospective Validation of a Pathology-Based Artificial Intelligence Model for Predicting the Time to Castration Resistance of Prostate Cancer","Inclusion Criteria:\n\n1. Patients are diagnosed with intermediate- to high-risk prostate cancer; undergo prostate biopsy\n2. Patients only received endocrine therapy for prostate cancer;\n3. Patients with complete clinical and pathological information.\n4. Patients agree to participate in this diagnostic test.\n\nExclusion Criteria:\n\n1. Patients with other tumors and undergo systemic therapy .\n2. The patient refused to participate in this diagnostic test.",{"count":245,"type":21},150,"The goal of this predictive test is to prospectively test the performance of pre-developed artificial intelligence (AI) predictive model for predicting the time to castration resistance of prostate cancer. Investigators had developed this AI model based on deep learning algorithms in preliminary research, and it performed well in retrospective tests.",[25],[249,250,251,252],"artificial intelligence","time to castration-resistant","prostate cancer","whole slide image","2026-01-21",{"date":255,"type":37},"2026-01-29",{"date":257,"type":21},"2026-01-01",{"date":259,"type":21},"2028-12-31",{"name":261,"class":262},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",1,{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":93,"phases":273,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":263},"100496391","phase-1-study-of-tvb-2640-in-men-with-metastatic-castration-resistant-prostate-cancer-100496391","NCT05743621","Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer","A Phase I, Open-Label, Dose-Finding Study of TVB-2640 Administered in Combination With Enzalutamide (Xtandi) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n* Age \\>18 years\n* Documented histological or cytological diagnosis of PC\n* Evidence of metastatic PC on imaging (bone scan and\u002For CT\u002FMRI scan)\n* Diagnosis of progressive metastatic, castration resistant prostate cancer\n* Potential participant must be planning to receive Enzalutamide as their first line of therapy for castration resistant prostate cancer or have previously received up to one line of Abiraterone or an androgen receptor antagonist\n* Willing to undergo a tumor biopsy prior to beginning therapy, if recent tissue samples are not available\n* Willing to undergo a tumor biopsy of at least one metastatic site or primary prostate after \\~4-6 weeks of therapy with both agents\n* Participants without prior orchiectomy must be currently taking and willing to continue luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) therapy until permanent discontinuation of study treatment\n* ECOG performance status of 0-1\n* Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless specified below AE(s) are clinically nonsignificant and\u002For stable on supportive therapy\n* Adequate organ and marrow function, based upon laboratory criteria within 14 days before first dose of study treatment\n* Sexually active, fertile participants and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom with spermicide during the course of the study and for 4 months after the last dose of study treatment\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document\n\nExclusion Criteria:\n\n* Receipt of any type of biologic, or other systemic anticancer therapy (including investigational) except agents within 4 weeks before first dose of study treatment. Anti-resorptive bone agents are also allowed.\n* Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n* Prior exposure to taxane chemotherapy\n* History of pneumonitis\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Participants must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible participants must be neurologically asymptomatic and without corticosteroid treatment for neurological indications at the time of first dose of study treatment.\n* Participants with clinically significant dry eye or corneal abnormalities\n* Currently taking certain anticoagulation medications, such as coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel)\n* Participant has prothrombin time (PT)\u002FINR or partial thromboplastin time (PTT) test ≥ 1.3 X the laboratory ULN within 30 days before the first dose of study treatment.\n* Participants should not receive strong CYP2C8 or strong P-gp inhibitors; strong CYP3A4 or CYP2C8 inducers; and strong CYP3A4, CYP2C9 and CYP2C19 substrates while participating in the trial, unless utilized with caution to treat a drug-related AE when no alternative is available and discussed with the Medical Monitor.\n* Participant has uncontrolled, significant intercurrent or recent Cardiovascular disorders including, but not limited to, the following conditions:\n\n  i. Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.\n\nii. Uncontrolled hypertension defined as sustained blood pressure (BP) \\>140 mm Hg systolic or \\>90 mm Hg diastolic despite optimal antihypertensive treatment.\n\niii. Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g. deep venous thrombosis, pulmonary embolism) within 6 months before first dose.\n\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 470 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment.\n* Inability to swallow tablets.\n* Use of herbal products that may decrease PSA levels within 4 weeks prior to enrollment\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations.\n* Diagnosis of another type of cancer within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy.\n* Any serious and\u002For unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.",{"count":272,"type":21},30,[95],"The purpose of this study is to determine what effects (good and bad) Enzalutamide and TVB-2640 have in the treatment of prostate cancer whose prostate cancer has spread to other parts of their body and that has not gotten better with previous treatment. This study is a Phase I clinical trial. Phase I clinical trials test the side effects of an investigational drug or an investigational combination with another drug. \"Investigational\" means that the drug is still being studied and research doctors are trying to find out more about it. Although Enzalutamide is already being used to treat men with prostate cancer, combining Enzalutamide with TVB-2640 together in patients with prostate cancer is considered experimental. This research study is being done because additional effective treatments are needed for prostate cancer that has spread and is growing despite hormone suppression. By doing this study, the investigators hope to learn if combining Enzalutamide with TVB-2640 can be done safely. Participation in this research will last about 12 to 24 months after enrollment.",[25],[58,277],"FASN Inhibitor","2025-11-17",{"date":280,"type":37},"2025-11-21",{"date":282,"type":37},"2023-11-20",{"date":284,"type":21},"2029-01-25",{"name":286,"class":262},"Weill Medical College of Cornell University",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":90,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":93,"phases":295,"briefSummary":296,"conditions":297,"keywords":309,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":324},"100511807","phase-1-htl0039732-in-participants-with-advanced-solid-tumours-100511807","NCT05944237","HTL0039732 in Participants With Advanced Solid Tumours","A Cancer Research UK Phase I\u002FIIa Trial of HTL0039732, Given Orally as Monotherapy and in Combination With Immunotherapy or Other Approved Therapies in Participants With Advanced Solid Tumours","Inclusion Criteria:\n\n1. Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product administration and follow-up.\n2. Phase 1, dose escalation phase\n\n   Part A (HTL0039732 monotherapy):\n   * Histologically or cytologically proven advanced solid tumour, refractory to conventional treatment, or for which no further conventional therapy is considered appropriate by the Investigator or is declined by the potential participant.\n   * At least 1 measurable lesion according to RECIST v1.1, which (in the Investigator's opinion) has had objective radiological progression on or after the last therapy, or at least one assessable lesion e.g. pleural or peritoneal thickening that does not fulfil RECIST v1.1 criteria for measurable disease.\n\n     a. Consent for fresh tumour biopsy sample(s) at time of PD, if the participant has accessible disease and is eligible to receive atezolizumab. Optional at time of disease progression.\n   * Consent to access and analysis of any available archival tissue or a fresh tumour sample at baseline, if archival tissue is unavailable.\n   * Consent for fresh tumour biopsy sample(s) at time of PD, if the participant has accessible disease and is eligible to receive atezolizumab. Optional at time of disease progression.\n\n   Phase 1 Part B:\n\n   \\- Histologically proven advanced solid tumour where PGE2\u002FEP4 signalling is believed to be more prevalent or significant (such as microsatellite stable colorectal cancer (MSS CRC), gastro-esophageal cancer, head and neck squamous cell carcinoma (HNSCC), mCRPC, pancreatic cancer, lung cancer, bladder cancer, mesothelioma, cervical cancer, renal cancer, sarcoma, pheochromocytoma and cancers with PI3K\u002FAKT\u002FmTOR pathway activating mutations using a clinically-validated assay).\n\n   Phase 2a:\n\n   \\- Histologically proven advanced solid tumour, in line with indications listed below, refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the potential participant:\n   1. MSS CRC with PIK3CA or HER2 mutation, and\u002For other driver mutation as agreed with the Sponsor (genomic alteration to have been previously identified using a validated next-generation sequencing method performed on either tumour tissue or circulating tumour DNA \\[ctDNA\\]);\n   2. Gastric or gastroesophageal junction (GOJ) adenocarcinoma;\n   3. Clear cell renal cell carcinoma;\n   4. mCRPC\n\n   Phase 1 Part B and Phase 2a:\n   * Consent to access and analysis of any available archival tissue.\n   * Consent for fresh tumour biopsy samples at baseline and on treatment. However, the following exceptions will be permitted if archival tissue is available at the recruiting site:\n\n     1. Patients with mCRPC: biopsies are not required for those whose only safely accessible lesions are bone metastases that lack an accessible soft tissue component.\n     2. For the first 12 participants in each indication: the on-trial biopsy is optional; and the baseline biopsy is mandatory if there is a safely accessible lesion but may be omitted for patients who have no safely accessible lesion, to permit their inclusion in the study. This will continually be assessed through the study.\n   * Disease refractory to conventional treatment, or for which no further conventional therapy is considered appropriate by the Investigator or is declined by the participant.\n   * Except for mCRPC, at least 1 measurable lesion according to RECIST v1.1, which (in the Investigator's opinion) has had objective radiological progression on or after the last therapy. Potential participants with mCRPC may instead have had PD according to PCWG3 criteria.\n\n     1. Previously irradiated lesions cannot be counted as target lesions unless clearly progressed after the radiotherapy.\n     2. Lesions that are intended to be biopsied should not be counted as target lesions (those undergoing biopsy must have at least one target lesion that is not intended to be biopsied).\n   * For indications where anti-PD-1\u002FPD-L1 therapy is standard of care (such as clear cell renal cell carcinoma, or gastric or GOJ adenocarcinoma with elevated PD-L1 expression), patients must have received that therapy and must be considered to have had progressive disease by the Investigator either on, or within 6 months after, that treatment.\n3. Life expectancy of at least 12 weeks.\n4. Eastern Cooperative Oncology Group performance status of 0 or 1.\n5. Haematological and biochemical indices within the protocol specified ranges.\n6. Stable thyroid function tests. Stable doses of thyroxine replacement are permitted.\n7. Aged 18 years or over at the time consent is given.\n\nExclusion Criteria:\n\n1. Radiotherapy (except for palliative reasons), chemotherapy, non chemotherapy systemic anti-cancer therapy (apart from life-long hormone suppression such as luteinising hormone-releasing agents in participants with mCRPC) or investigational medicinal products during the 4 weeks prior to enrolment; or first dose of an immunotherapy during the previous 12 weeks before first dose of HTL0039732.\n2. Ongoing toxic manifestations of previous treatments that are Grade \\>1 per CTCAE v5.0.\n3. Any central nervous system metastases (unless potential participants have had local therapy and are asymptomatic, radiologically stable and have been off steroids for ≥4 weeks prior to enrolment).\n4. Women of child-bearing potential (or who are already pregnant or lactating). Exceptions apply.\n5. Men with partners of childbearing potential. Exceptions apply.\n6. Major thoracic or abdominal surgery from which the potential participant has not yet recovered.\n7. At high medical risk because of non-malignant systemic disease, including active uncontrolled infection.\n8. Known history of current or latent tuberculosis, HIV or Hepatitis B or C infection.\n9. Prior treatment with EP4 inhibitor.\n10. Treatment with selective cyclooxygenase-2 inhibitor in the 8 weeks prior to enrolment.\n11. Known hypersensitivity or intolerance to hydroxypropyl methylcellulose.\n12. Use of systemic immunosuppressive agent in the 2 weeks prior to enrolment. Exceptions apply.\n13. Significant cardiovascular disease.\n14. Known active peptic ulcer disease, or symptoms of gastritis, dyspepsia or gastro-esophageal reflux disease (one or more episodes per week).\n15. Current or planned participation in another interventional clinical trial, whilst taking part in this trial of HTL0039732.\n16. Limited ability to swallow or absorb oral medications.\n17. Any other condition that, in the Investigator's opinion, would mean that the trial is not in the best interests of the potential participant.\n\n    Phase 1 Part B and Phase 2a:\n18. Any live vaccines in the 4 weeks prior to enrolment.\n19. Diagnosis of immunodeficiency.\n20. Active autoimmune disease requiring systemic treatment in the 2 years prior to enrolment.\n21. History or clinical suspicion of interstitial lung disease, history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.\n22. Hypersensitivity to atezolizumab or any of its excipients.\n23. Prior adverse reaction to cancer immunotherapy that required steroid or other immunosuppressive treatment or led to discontinuation of that treatment.",{"count":245,"type":21},[95,96],"The purpose of this trial is to evaluate a new drug, HTL0039732, that will be administered on its own (as a monotherapy) and in combination with atezolizumab or with other approved anti-cancer therapies, in participants with advanced solid tumours.",[116,25,298,299,300,301,302,303,304,102,305,306,307,308],"Stomach Neoplasms","Esophageal Neoplasms","Head and Neck Neoplasms","Colorectal Neoplasms","Pancreatic Neoplasms","Lung Neoplasms","Urinary Bladder Neoplasms","Uterine Cervical Neoplasms","Kidney Neoplasms","Sarcoma","Pheochromocytomas",[310,311,312,313,314],"EP4 antagonist","Anti-PD-1\u002FPD-L1 agents","PGE2","EP4","COX inhibitor","2025-06-05",{"date":317,"type":37},"2025-06-08",{"date":319,"type":37},"2023-07-13",{"date":321,"type":21},"2027-06",{"name":323,"class":262},"Cancer Research UK",5,{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":93,"phases":334,"briefSummary":336,"conditions":337,"keywords":344,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":263},"100570413","phase-4-18f-fluciclovine-petct-impact-on-predicting-clinical-outcome-of-177lu-psma-617-therapy-in-patients-with-prostate-cancer-100570413","NCT06706921","18F-Fluciclovine PET\u002FCT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer","Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET\u002FCT Predicting Clinical Outcome","Inclusion Criteria:\n\n* Patients with mCRPC scheduled to undergo LuPSMA RLT.\n* Willingness to undergo multiple serial PET\u002FCT scans pre- and post-LuPSMA RLT.\n* Ability of providing written informed consent.\n\nExclusion Criteria:\n\n* Less than 18 years-old at the time of radiopharmaceutical administration.\n* Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.\n* Contraindications to LuPSMA RLT.",{"count":333,"type":21},15,[335],"PHASE4","This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography\u002Fcomputed tomography 18F-FDG PET\u002FCT and a 18F-DCFPyL PET\u002FCT (18F-DCFPyL (2-(3-{1-carboxy-5-\\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography\u002Fcomputed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography\u002Fcomputed tomography ( Axumin PET\u002FCT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET\u002FCT will be acquired within 7 days from the PSMA PET.\n\nThis study is open to Veterans only.",[338,25,339,340,341,220,219,116,114,342,343],"Prostatic Neoplasms","Metastatic Prostate Cancer","Male Urogenital Diseases","Prostatic Diseases","Urogenital Neoplasms","Genital Neoplasms, Male",[345,346,347,58,348],"Prostate cancer","PET\u002FCT","Radioligand Therapy","PSMA PET","2024-11-26",{"date":351,"type":37},"2024-11-27",{"date":353,"type":21},"2024-12-15",{"date":355,"type":21},"2027-11-01",{"name":357,"class":358},"VA Greater Los Angeles Healthcare System","FED",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":93,"phases":369,"briefSummary":370,"conditions":371,"keywords":372,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":385},"100469513","phase-2-phase-ii-randomised-controlled-trial-of-patient-specific-adaptive-vs-continuous-abiraterone-or-enzalutamide-in-mcrpc-100469513","NCT05393791","Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC","ANZadapt: Phase II Randomised Controlled Trial of Patient-specific Adaptive Versus Continuous Abiraterone or eNZalutamide in Metastatic Castration-resistant Prostate Cancer","ANZadapt","Inclusion Criteria:\n\n1. Willing and able to provide informed consent;\n2. Aged 18 or older;\n3. Histologically or cytologically confirmed adenocarcinoma of the prostate;\n4. Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (i.e. surgical or medical castration with testosterone at screening ≤1.7 nmol\u002FL (\\\u003C0.5 ng\u002FmL)); patients who have not had a bilateral orchiectomy, must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial;\n5. Presence of metastatic disease on WBBS and\u002For CT-scan;\n6. Progressive disease at study entry defined as per PCWG3 as one or more of the following criteria that occurred while the patient was on ADT:\n\n   1. PSA progression defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (≥4 weeks since last flutamide or ≥6 weeks since last bicalutamide or nilutamide); OR\n   2. Radiographic PD on bone scintigraphy and\u002For CT-scan;\n7. A PSA concentration of ≥2 ng\u002FmL.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n9. Controlled symptoms (opioids for cancer related pain stable for \\>4 weeks, no need for urgent radiotherapy for symptomatic lesions);\n10. Estimated life expectancy of ≥12 months;\n11. Patient has archival prostate cancer tissue available and which he consents to share or is willing to undergo a new tumour biopsy;\n12. Adequate organ function: absolute neutrophil count \\> 1,500\u002FμL (\\> 1.5\\*109\u002FL); platelet count \\> 100,000\u002FμL (\\> 100\\*109\u002FL), haemoglobin \\> 90 g\u002FL; total bilirubin \\\u003C 1.5 times ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 3 times ULN; creatinine \\\u003C 175 μmol\u002FL; albumin \\> 30 g\u002FL;\n13. Any other therapies for CRPC (excluding denosumab and bisphosphonates) have to be discontinued 3 weeks prior to study randomisation;\n14. Able to swallow the study drug and comply with study requirements.\n\nExclusion Criteria:\n\n1. Life-threatening or serious medical or psychiatric illness that could, in investigator's opinion, potentially interfere with participation in this study;\n2. Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs. Potential participants with non-melanoma skin cancer, non-muscle invasive bladder cancer, or carcinoma in situ of any type are allowed if they have undergone complete resection;\n3. Known or suspected brain metastasis or leptomeningeal disease;\n4. Small-cell or neuroendocrine differentiation of prostate cancer;\n5. Radiation therapy for treatment of the primary tumour within 3 weeks of screening visit;\n6. Radiation or radionuclide therapy for treatment of metastasis within 3 weeks of screening visit, excluding radiation to reduce pain symptoms;\n7. History of uncontrolled seizures (if patient and investigator wish to choose treatment with enzalutamide)\n8. Unstable symptomatic ischemic heart disease, ongoing arrhythmias or New York Heart Association (NYHA) Class III or IV heart failure;\n9. Known HIV infection, active chronic hepatitis B or C;\n10. Known gastrointestinal (GI) disease that could interfere with GI absorption\u002Ftolerance of study drugs;\n11. Prior treatments with CYP17 inhibitors (e.g. ketoconazole) or novel androgen receptor inhibitors (e.g. abiraterone, apalutamide, darolutamide or enzalutamide). Bicalutamide and nilutamide should be stopped \\>6 weeks before screening visit. Prior treatment with docetaxel in the mHSPC setting is allowed.\n12. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.",{"count":368,"type":21},168,[96],"Hormone tablets, abiraterone (Zytiga®) and enzalutamide (Xtandi®) are approved to treat advanced prostate cancer. However, even if these drugs are helpful, their effectiveness usually diminishes over time. Small pilot studies have indicated that using hormone tablets sparingly, for just long enough to control the cancer, followed by a break in treatment and restarting them later, seems to improve how long hormone tablets can control the cancer. This study aims to find out if this pause\u002Frestart strategy is better than taking hormone tablets every day continuously. The study will include 168 people with metastatic castrate resistant prostate cancer in the Netherlands and Australia. Patients will be randomly 1:1 assigned between the control group and the experimental group. In the control group, patients will take the treatment with AA\u002FENZ every day until the prostate cancer doesn't respond anymore to the treatment. In the experimental group, patients will start with daily AA\u002FENZ until the PSA has declined for \\>50%. The treatment will then be paused and monthly PSA measurements will be performed. The treatment will be re-initiated when the PSA has increased to the level of before starting treatment. The treatment will be continued daily until the PSA has again dropped for \\>50%. This pause\u002Frestart cycle will be repeated until the prostate cancer doesn't respond anymore to the treatment.",[25],[373,374,375,376],"Antineoplastic Agents, Hormonal","Evolution","Quality of Life","Prostatic Neoplasms, Castration-Resistant \u002F drug therapy","2024-11-25",{"date":349,"type":37},{"date":380,"type":37},"2022-11-10",{"date":382,"type":21},"2027-11-10",{"name":384,"class":262},"Leiden University Medical Center",19]