[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"castration-resistant-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:castration-resistant-prostate-cancer":419},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,62,87,113,144,170,192,214,238,264,283,307,334,357,384,407,429],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100631678","phase-1-a-study-of-ide034-in-adult-participants-with-locally-advancedmetastatic-solid-tumors-types-100631678",false,"NCT07503808","A Study of IDE034 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors Types","An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Participant must be at least 18 years of age or the age of maturity per local regulations\n2. Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 \\[HER2\\] negative), CRC, and CRPC who have radiologically progressed or recurred on at least one line of therapy or is intolerant to additional effective standard therapies.\n3. Archival tissue sample for testing\n4. Measurable disease\n5. Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n6. Have adequate bone marrow and organ function.\n7. Able to comply with contraceptive\u002Fbarrier requirements\n\nExclusion Criteria:\n\n1. Known symptomatic brain metastases or leptomeningeal metastasis\n2. Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose.\n3. Have uncontrolled tumor-associated pain\n4. Have clinically significant cardiac abnormalities and\u002For cerebrovascular disease (stroke) within 6 months before the first dose\n5. Active uncontrolled infection\n6. Have history of interstitial pneumonitis, current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose.\n7. Have history of severe infections within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization.\n8. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening.\n9. Participants with known or suspected viral hepatitis\n10. Have history of active tuberculosis within 1 year before enrollment\n11. If participants had adverse reactions to previous antitumor treatment that have not recovered to guidelines of CTCAE Grade ≤ 1 and Grade 2 peripheral neurological symptoms\n12. Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 3 weeks before the first dose of IMP or other investigational products within 4 weeks of first dose of IMP\n13. Administration of any of the following\n\n    1. Current use or anticipated need for food or drugs that are known strong CYP3A4\u002F5 inhibitors or inducers\n    2. Have prior treatment with B7-H3 or PTK7 antibody-drug conjugate (ADC).\n    3. Have prior treatment with a topoisomerase I inhibitor (TOP1i), including an ADC with a TOP1i payload, within 6 months of first dose of IMP\n    4. Have received radiotherapy within 2 weeks prior to study entry\n    5. Have undergone major surgery or trauma within 4 weeks prior to study entry.\n    6. Have received live attenuated vaccine within 28 days prior to the first dose or are expected to receive live attenuated vaccine during the study treatment.\n    7. Female participants who are pregnant, lactating, or planning to become pregnant during the study period to 7 months after the last dose of IMP.\n    8. Are known to be allergic to any component or excipient of the IMP product or have a history of severe allergic reactions to other monoclonal antibody\u002Ffusion protein drugs.\n    9. Participants with complications in the eye including ulcers in the eye, and severe dry eye","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1a\u002F1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced\u002Fmetastatic solid tumor types that express B7-H3 and PTK7.",[26,27,28,29,30,31,32,33],"Esophageal Squamous Cell Carcinoma","High Grade Serous Ovarian Cancer","Head and Neck Squamous Cell Carcinoma","Colorectal Cancer","Castration-resistant Prostate Cancer","Non Small Cell Lung Cancer","Endometrium Cancer","Triple Negative Breast Cancer",[26,35,36,28,37,38,39,29,40,30,41,42,43,44,45,46,47,48],"ESCC","Endometrial Cancer","HNSCC","Triple-negative Breast Cancer","TNBC","CRC","CRPC","Non-small Cell Lung Cancer","NSCLC","High-grade Serous Ovarian Cancer","HGSOC","Advanced, Metastic Solid Tumors","B7-H3 (CD276) and Protein Tyrosine Kinase 7 (PTK7)","IDE034","RECRUITING","2026-06-16",{"date":52,"type":53},"2026-06-18","ACTUAL",{"date":55,"type":53},"2026-02-24",{"date":57,"type":20},"2027-07-30",{"name":59,"class":60},"IDEAYA Biosciences","INDUSTRY",15,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100643113","phase-2-a-study-of-bl-b01d1-combination-therapy-in-patients-with-metastatic-castration-resistant-prostate-cancer-100643113","NCT07641855","A Study of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer","A Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n1. Voluntarily join this study and sign the informed consent form;\n2. Age ≥ 18 years;\n3. Expected survival time ≥ 3 months;\n4. Unresectable metastatic castration-resistant prostate cancer;\n5. Meet the definition of mCRPC according to PCWG3 criteria;\n6. Agree to provide archived tumor tissue specimens from primary or metastatic lesions within 3 years or fresh tissue samples;\n7. Meet the evaluable lesion requirement defined by any one of the following assessment criteria;\n8. ECOG performance status score of 0 or 1;\n9. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;\n11. Organ function levels must meet the required criteria;\n12. Urine protein ≤ 1+ or \\\u003C 1000 mg\u002F24h;\n13. All enrolled patients must use adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Patients with metastatic castration-resistant prostate cancer who are suitable for radical local therapy;\n2. Patients with non-prostatic acinar adenocarcinoma confirmed by histopathology or cytology, among others;\n3. Patients who have previously received antibody-drug conjugates using topoisomerase I inhibitors as the toxin, among others;\n4. Use of chemotherapy, targeted therapy, biological therapy, etc., within 4 weeks or 5 half-lives prior to study randomization;\n5. History of severe heart disease or cerebrovascular disease;\n6. Long-term systemic corticosteroid therapy with prednisone \\>10 mg\u002Fday ongoing before the first dose, among others;\n7. Active autoimmune diseases and inflammatory diseases;\n8. Any thrombotic event within 6 months prior to randomization;\n9. Prolonged QTc interval, complete left bundle branch block, etc.;\n10. Diagnosis of active malignant tumors within 3 years prior to study randomization;\n11. Hypertension inadequately controlled by two antihypertensive medications;\n12. Patients with poorly controlled blood glucose;\n13. History of ILD requiring steroid therapy, or current ILD, or grade ≥2 radiation pneumonitis;\n14. Concurrent pulmonary diseases resulting in clinically severe respiratory function impairment;\n15. Patients with active central nervous system metastases;\n16. Severe infection occurring within 4 weeks prior to study randomization, etc.;\n17. Presence of large serous cavity effusion, or serous cavity effusion with symptoms, etc.;\n18. Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;\n19. Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;\n20. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;\n21. Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, intestinal obstruction, or chronic diarrhea, etc.;\n22. Patients with a history of allergy to recombinant humanized antibodies or allergy to the investigational drug;\n23. History of autologous or allogeneic stem cell transplantation;\n24. Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;\n25. History of severe neurological or psychiatric disorders;\n26. Receipt of other unapproved clinical investigational drugs or treatments within 4 weeks prior to study randomization;\n27. Trial participants planning to receive vaccination or having received live vaccines within 28 days prior to study randomization;\n28. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.",{"count":70,"type":20},180,[72,73],"PHASE2","PHASE3","This study will first conduct a phase II clinical study, and on the basis of the phase II clinical study, subsequent clinical research will be carried out.",[30],"NOT_YET_RECRUITING","2026-06-08",{"date":79,"type":53},"2026-06-11",{"date":81,"type":20},"2026-06",{"date":83,"type":20},"2028-12",{"name":85,"class":60},"Sichuan Baili Pharmaceutical Co., Ltd.",2,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100590331","phase-1-study-of-dcc-2812-in-participants-with-advanced-genitourinary-cancers-100590331","NCT06966024","Study of DCC-2812 in Participants With Advanced Genitourinary Cancers","An Open-label, Phase 1 Study of DCC-2812 Monotherapy in Participants With Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer","Key Inclusion Criteria:\n\n* Have confirmed Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer\n* Able to take oral medication\n* If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements\n* Adequate organ function and electrolytes\n\nKey Exclusion Criteria:\n\n* Received any prior anticancer therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-2812\n* Impaired cardiac function\n* Major surgery within 28 days of the first dose of study drug",{"count":95,"type":20},60,[23],"This is a multicenter clinical trial to evaluate the safety and preliminary activity of the selective general control nonderepressible 2 (GCN2) activator DCC-2812 as monotherapy in advanced\u002Fmetastatic renal cell carcinoma (RCC), urothelial carcinoma, and castration-resistant prostate cancer.",[99,100,30],"Renal Cell Carcinoma","Urothelial Carcinoma",[102],"Advanced malignancies","2026-05-18",{"date":105,"type":53},"2026-05-20",{"date":107,"type":53},"2025-08-27",{"date":109,"type":20},"2029-02",{"name":111,"class":60},"Deciphera Pharmaceuticals, LLC",5,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":143},"100325826","phase-2-bipolar-androgen-therapy--carboplatin-in-mcrpc-100325826","NCT03522064","Bipolar Androgen Therapy + Carboplatin in mCRPC","High Dose Testosterone + Carboplatin in Men With Advanced Prostate Cancer","HiTeCH","Inclusion Criteria:\n\n1. Males with histologically confirmed adenocarcinoma of the prostate\n2. Confirmed HRD (Homologous recombination defect) in germline and\u002For somatic DNA analysis (tumour or blood), by a validated assay (see Appendix 1). Mutations in HR genes not listed in appendix 1 will be considered in literature suggests pathogenicity. A maximum of 10 uncharacterised or heterozygous mutations will be included.\n3. Age ≥ 18 years\n4. ECOG performance status ≤ 1\n5. Rising PSA confirmed on two sequential tests ≥1 week apart and a minimum value of 2 ug\u002FL despite castrate levels of testosterone\n6. Serum testosterone \\\u003C 1.7 nmol\u002FL and on an LHRH agent or post orchidectomy ≥ 1 year.\n7. Washout of ≥ 4 weeks from prior line of treatment, radiotherapy or surgery (aside from LHRH agent)\n8. Adequate bone marrow function (platelets \\> 100 x 109\u002FL, ANC \\> 1.5 x 109\u002FL, Hb \\>100)\n9. Adequate liver function (ALT\u002FAST \\\u003C 1.5 x ULN, bilirubin \\\u003C 2 x ULN)\n10. Adequate renal function (creatinine clearance \\> 50 ml\u002Fmin)\n11. Adequate cardiac function and reserve after cardiology assessment\n12. Archived tissue sample available or willingness to undergo fresh biopsy\n13. Willing and able to comply with all study requirements, including treatment, timing and\u002For nature of required assessments\n14. Signed, written informed consent\n\nExclusion Criteria:\n\n1. Contraindications to investigational product\n2. Pain due to metastatic prostate cancer requiring opioid analgesics\n3. Evidence of disease progression in sites or extent that, in the opinion of the investigator, would put the patient at risk from testosterone therapy and its potential for initial tumour flare (eg: femoral metastasis at risk of fracture, ureteric obstruction due to nodal disease or cord compression due to spinal metastases).\n4. Previous treatment with platinum chemotherapy and\u002For a PARP inhibitor. However up to 8 men with prior treatment to these agents will be included as an exploratory cohort.\n5. Life expectancy of less than 3 months.\n6. Brain metastases or leptomeningeal disease\n7. History of thromboembolic event and not currently on anticoagulation\n8. Prior myocardial infarction or unstable angina within 2 years of study entry\n9. Haematocrit ≥ 50%, untreated severe obstructive sleep apnoea or poorly controlled heart failure (NYHA \\>1)\n10. History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.\n11. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.\n12. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.","MALE",{"count":123,"type":20},30,[72],"The purpose of this study is to determine the efficacy of BAT and carboplatin in men with metastatic castrate-resistant prostate cancer (mCRPC).",[30,127],"Homologous Recombination Deficiency",[129,130,131,132],"Castrate-resistant prostate cancer","bipolar androgen therapy","homologous recombination deficiency","BRCA","2026-04-22",{"date":135,"type":53},"2026-04-23",{"date":137,"type":53},"2018-07-30",{"date":139,"type":20},"2027-12-30",{"name":141,"class":142},"St Vincent's Hospital, Sydney","OTHER",1,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100545205","phase-2-stereotactic-body-radiation-therapy-plus-immediate-or-delayed-androgen-receptor-pathway-inhibitor-and-androgen-deprivation-therapy-or-salvage-radiation-therapy-for-the-treatment-of-prostate-cancer-divine-trial-100545205","NCT06378866","Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial","MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer","DIVINE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease characteristics:\n\n  * DEVIATE (Groups A and B only):\n\n    * Clinical confirmation of metachronous (metastatic) recurrent hormone-sensitive prostate cancer\n    * Five (5) or fewer metastases with at least one metastasis beyond the pelvis on advanced molecular and\u002For conventional imaging\n    * Serum testosterone \\> 100ng\u002FdL\n  * BRIO (Gropus C \\& D only):\n\n    * Prostate-specific antigen (PSA) between 0.2 and 1.5 ng\u002FmL with PSA above 0.2 on at least two consecutive measurements at least 5 days apart\n    * No local or metastatic recurrence apparent on advanced molecular imaging\n    * Serum testosterone \\> 100 ng\u002FdL\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n* Hemoglobin ≥ 8.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 80,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x upper limit of normal (ULN) ( ≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)\n* Calculated creatinine clearance ≥ 30 ml\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide tissue specimens for correlative research\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Prior metastasis-directed therapy\n* Any of the following prior therapies:\n\n  * Surgery ≤ 3 weeks prior to registration\n  * Chemotherapy for prostate cancer at any time\n  * Androgen receptor pathway inhibitor such as abiraterone, apalutamide, darolutamide, or enzalutamide in the last 2 years\n* Uncontrolled intercurrent non-cardiac illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Any other conditions that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for prostate cancer.\n* Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy ≤ 3 years prior to registration\n\n  * EXCEPTIONS: Curatively treated non-melanotic skin cancer or papillary thyroid cancer\n  * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment such as chemotherapy or antihormonal therapy for their cancer\n* History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias",{"count":153,"type":20},532,[72],"This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). It also studies the effects of salvage radiation therapy (sXRT) on prostate cancer and to see if radiation to the pelvis helps prevent prostate cancer from spreading elsewhere. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. sXRT is a targeted radiation treatment for the prostate, typically given when cancer possibly returns after surgery or radiation. Its goal is to destroy any tumor cells in the area. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT and sXRT may be effective in treating prostate cancer and preventing it from spreading elsewhere.",[157,158,30,159],"Recurrent Castration-Sensitive Prostate Carcinoma","Recurrent Prostate Cancer","Biochemically Recurrent Prostate Carcinoma","2026-04-17",{"date":162,"type":53},"2026-04-20",{"date":164,"type":53},"2024-06-03",{"date":166,"type":20},"2031-02-28",{"name":168,"class":142},"Mayo Clinic",3,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":143},"100634909","phase-1-study-of-janx014-in-subjects-with-metastatic-castration-resistant-prostate-cancer-100634909","NCT07545811","Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer","A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With Prostate Cancer","Inclusion Criteria:\n\n* Male ≥18 years of age at the time of signing informed consent\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* For Dose Escalation: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible.\n* Adequate organ function\n* For Dose Expansion Part: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.\n\nExclusion Criteria:\n\n* Prior solid organ transplant\n* Prior treatment with any CAR-T cell therapy, approved or investigational T-cell engager therapy, and prior receipt of radioligand therapy\n* Clinically significant cardiovascular disease",{"count":178,"type":20},43,[23],"This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).",[182,183,30],"Prostate Cancer","Metastatic Castration-resistant Prostate Cancer","2026-04-16",{"date":133,"type":53},{"date":187,"type":53},"2026-04-15",{"date":189,"type":20},"2029-03",{"name":191,"class":60},"Janux Therapeutics",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":86},"100612871","phase-1-a-study-of-terbium-161-161tb-rad402-in-participants-with-crpc-100612871","NCT07259213","A Study of Terbium 161 (161Tb)-RAD402 in Participants With CRPC","A Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, Whole-Body Distribution, and Preliminary Clinical Activity of 161Tb-RAD402, a Radiolabeled Anti-Kallikrein-Related Peptidase 3 (KLK3) Monoclonal Antibody Targeting Free Prostate-Specific Antigen, in Participants With Castration-Resistant Prostate Cancer (CRPC)","RAD402","Inclusion Criteria:\n\n* Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n* Male participants ≥ 18 years of age.\n* Participants with a documented history of histopathologically confirmed locally advanced or metastatic CRPC defined as follows:\n\n  1. Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria:\n\n     * Serum PSA increase \\>25% and \\>2.0 ng\u002Fml above nadir, confirmed by progression at 2 timepoints at least 3 weeks apart (PCWG3)\n     * Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest sum of the diameter since the previous treatment was started or the appearance of one or more new lesions by computed tomography (CT)\u002F magnetic resonance imaging (MRI).\n     * Progression of bone disease defined by PCWG3 as evaluable disease or new bone lesions by bone scan (if metastatic disease).\n     * Identification of new soft tissue or bone lesions on PSMA PET imaging.\n  2. If metastatic disease, metastatic disease defined as either or both of the following:\n\n     * Documented M1 disease on conventional imaging (CT\u002FMRI of the chest\u002Fabdomen\u002Fpelvis and\u002For Technetium 99m \\[99mTc\\] whole-body bone scan)\n     * Identification of bone lesion(s), extra-pelvic soft tissue lesion(s), or visceral metastases on PSMA PET imaging with an FDA-approved imaging agent (e.g., Gallium-68 (68Ga)-PSMA-11)\n  3. PSMA PET-positive disease, defined as at least one PSMA-positive metastatic lesion PSMA PET-positive lesions are defined as uptake greater than that of liver parenchyma in one or more extra-pelvic metastatic lesions of any size in any organ system using an FDA-approved PSMA PET imaging agent.\n  4. Progression following treatment with androgen deprivation therapy (ADT) and at least one androgen receptor signaling inhibitor (ARSI) (e.g., enzalutamide, apalutamide, darolutamide, and\u002For abiraterone acetate). If a participant is currently on ADT, they should continue ADT for the duration of their participation in the study but will not be permitted to start a new therapy or ADT regimen. If a participant has progressed on an ARSI, they will have the option to remain on the same ARSI or discontinue therapy.\n  5. Prior definitive and palliative external beam radiation therapy and stereotactic body radiation therapy is allowed.\n\nNote: Participants with extended external beam radiation therapy to the axial skeleton, which in the opinion of the Investigator may pose a risk for increased myelotoxicity, will be discussed with the Sponsor to determine eligibility.\n\n* Prior treatment with lutetium (Lu-177)-PSMA-radioligand (RL), defined as up to 6 doses of lutetium (177Lu) vipivotide tetraxetan (Pluvicto) or investigational use of up to 4 doses of Lu-177-PSMA-imaging and treatment (I\\&T) is allowed but not required.\n\n  a. Prior treatment with (no more than) one taxane-based chemotherapy is allowed but not required. A taxane-based chemotherapy is defined as a minimum exposure of two cycles of a taxane chemotherapy.\n* Participants must have documented disease progression during or after their most recent line of anticancer therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n* Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.\n* Participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 6 months after the last dose of 161Tb-RAD402. All participants must agree to not donate sperm during the study and for 6 months after the last dose of 161Tb-RAD402.\n* Participants with previously treated brain metastases are eligible to participate if:\n\n  1. they are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality (MRI or CT scan) must be used for each assessment) for at least 28 days prior to the first dose of 161Tb-RAD402; and\n  2. do not require corticosteroids at a dose of \\>10 mg prednisolone equivalent to treat associated neurological symptoms, and\n  3. have no history of leptomeningeal disease or spinal cord compression.\n\nExclusion Criteria:\n\n* Prostate cancer with known significant sarcomatoid, or spindle cell, or neuroendocrine small cell components, or metastasis of other cancer to the prostate.\n* History of prior organ transplant (other than corneal transplant)\n* Any other known, active malignancy except for non-melanoma skin cancer or adequately treated non-muscle-invasive urothelial carcinoma of the bladder (i.e. tumor in situ (Tis), tumor grade a (Ta) and low-grade tumor grade 1 (T1) tumors). Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and\u002For interfere with the integrity of the study outcome.\n* Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures, etc.\n* Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia and peripheral sensory neuropathy).\n* History of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to protein therapeutics, 161Tb-RAD402, or any of its excipients.\n* Inadequate organ functions as reflected in laboratory parameters:\n\n  * Estimated glomerular filtration rate (eGFR) \\\u003C 50 mL\u002Fmin adjusted for body surface area (BSA) using the Chronic Kidney Disease Epidemiology Collaboration formula\n  * Platelet count of \\\u003C 100 x 109\u002FL\n  * Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL\n  * Hemoglobin \\\u003C 9 g\u002FdL\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 x upper limit of normal (ULN), or \\> 5 x ULN for participants with known liver metastases\n  * Total bilirubin \\> 1.5 x ULN, except for participants with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 x ULN\n  * For participants not taking warfarin or other anticoagulants: International Normalised Ratio (INR) ≤1.5 or PT ≤1.5 x ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ≤1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \\\u003C3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.\n* Participants requiring blood product transfusion within 2 weeks of first dose of 161Tb-RAD402 are not eligible to participate.\n* Clinically significant cardiovascular disease including but not limited to:\n\n  * Unstable angina\n  * Acute myocardial infarction within 6 months prior to screening\n  * New York Heart Association (NYHA) Class II or greater congestive heart failure\n  * Clinically significant abnormalities in rhythm, conduction or morphology on resting electrocardiogram (ECG) (e.g., complete left bundle branch block, third degree heart block)\n  * Known left ventricular ejection fraction (LVEF) \\\u003C 50%\n  * QT corrected using Fridericia's formula (QTcF) \\> 480 msec on screening ECG, or congenital long QT syndrome.\n* Participation in any other interventional investigational trial for treatment of the underlying malignancy at the time of informed consent signature.\n* Major surgery within 4 weeks prior to first dose of 161Tb-RAD402.\n* Received prior therapy with a poly (ADP-ribose) polymerase (PARP) inhibitor or radium Ra 223 dichloride (Xofigo). Prior treatment with Lu-177-PSMA-radioligand (RL) is allowed.\n* Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, within 28 days (or 5 half-lives for biologic\u002Fnon-cytotoxic agents, whichever is shorter), prior to the first dose of 161Tb-RAD402. For participants who received radiotherapy more than 28 days prior to the first dose of 161Tb-RAD402, efforts should be made to calculate the prior radiation absorbed dose to each critical organ such as the kidneys, liver, lungs, and bone marrow.\n* Known active hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV) (defined as HCV ribonucleic acid (RNA) \\[qualitative\\] is detected) infection. Active viral (any etiology) hepatitis participants are excluded. Participants with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV deoxy ribonucleic acid (DNA) titer \\\u003C 1000 copies\u002FmL or 200 international units (IU)\u002FmL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Sponsor's Medical Monitor (or designee). Note, participants with a history of HCV infection should have completed curative antiviral treatment and have a viral load below the limit of quantification to be eligible to enroll into the study. No testing for HBV or HCV is required unless mandated by local health authority.\n* Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.\n* Untreated moderate to severe hydronephrosis. If hydronephrosis is corrected via stent or nephrostomy, hydronephrosis will be considered resolved.\n* Superscans by nuclear medicine\u002F99mTc bone scan.\n* Active autoimmune disease that has required systemic treatment within 90 days (i.e., with the use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid \\[stable \u002F low doses of ≤10 mg\u002Fday prednisone or equivalent dose\\]) for adrenal or pituitary insufficiency is not considered a form of systemic treatment and is allowed.\n* Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition (e.g., prior organ transplant), which in the judgment of the investigator could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the subject to safety risks.",{"count":201,"type":20},73,[23,72],"A Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, Whole-Body Distribution, and Preliminary Clinical Activity of 161Tb-RAD402, a Radiolabeled Anti-KLK3 Monoclonal Antibody Targeting Free Prostate-Specific Antigen, in Participants with Castration-Resistant Prostate Cancer (CRPC).",[30],"2026-03-30",{"date":207,"type":53},"2026-04-01",{"date":209,"type":53},"2026-03-05",{"date":211,"type":20},"2029-03-30",{"name":213,"class":60},"Radiopharm Theranostics, Ltd",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":226,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":169},"100480335","phase-2-study-of-apalutamide-with-carotuximab-in-metastatic-castration-resistant-prostate-cancer-100480335","NCT05534646","Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer","Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor: abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide will not be considered as contemporary ARSIs\n* Patient must have had 1 and can have up to 2 prior AR targeted therapy with the exception of apalutamide.\n* Patients must decline or be ineligible for taxane therapy in the opinion of the treating physician.\n* All patients must agree to use an adequate method of contraception, in the opinion of the treating investigator, while on protocol treatment and for 3 months after the last dose of protocol treatment (apalutamide and\u002For carotuximab)\n\nExclusion Criteria:\n\n* Non-PSA producing prostate cancers such as small cell prostate cancers or those prostate cancers which exhibit radiographic progression without PSA rise\n* Prior use of apalutamide\n* Other prior malignancy requiring active anticancer therapy\n* Prior exposure to carotuximab or any CD105 targeted antibody\n* Active bleeding or pathologic medical conditions that carries a high bleeding risk\n* A known diagnosis of Osler-Weber-Rendu syndrome",{"count":222,"type":20},100,[72],"This is an open-label, multi-site study of apalutamide with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin with a safety assessment in the first 10 subjects (part 1: Safety Lead-in). If the combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this study is to compare progression free survival (PFS) between patients receiving apalutamide and apalutamide + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3. The secondary objectives are to describe adverse events related to the intervention, overall response rate (ORR), proportion of patients resistant to apalutamide that benefit from the addition of carotuximab, and to determine the ORR, radiographic PFS, and biochemical PFS in the overall population.",[30],[227,228,41],"Prostate cancer","Castration-resistant","2026-01-29",{"date":231,"type":53},"2026-02-02",{"date":233,"type":53},"2023-12-27",{"date":235,"type":20},"2027-01",{"name":237,"class":142},"Edwin Posadas, MD",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":249,"conditions":250,"keywords":252,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":143},"100580394","phase-2-clinical-trial-to-test-efficacy-of-targeting-hypoxia-combined-with-arsi-after-first-line-arsi-therapy-for-castrate-resistant-prostate-cancer-100580394","NCT06836726","Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resistant Prostate Cancer","Phase II Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resistant Prostate Cancer","EVO","Inclusion Criteria:\n\n1. At least 18 years of age;\n2. Ability to understand the purposes and risks of the trial and has signed a written ICF approved by the investigator's REB;\n3. CRPC stage M1 based on conventional imaging (CT and\u002For bone scan) or PSMA PET;\n4. Progression (i.e., PSA rise of 25% or more, and absolute increase of 2 ng\u002FmL or more from the nadir) to first-line ARSIs (Abi or Enza or Daro or Apa monotherapy) and subsequent docetaxel or deemed ineligible for it;\n5. Ongoing castration therapy (e.g., surgical or medical with LHRH agonists\u002Fantagonist), with baseline testosterone level \\\u003C50ng\u002FdL;\n6. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2;\n7. In subjects with known significant pulmonary disease (severe chronic obstructive or other pulmonary disease with hypoxemia), measure oxygen saturation using pulse oximeter after a 2-minute walk. Subjects must have oxygen saturation ≥90% to be eligible for the trial.\n\nExclusion Criteria:\n\n* 1\\. ANC \\\u003C1,000\u002Fmm3, and\u002For hemoglobin \\\u003C9.0 g\u002FdL, and\u002For platelet count \\\u003C100,000\u002Fmm3; independent of transfusion and\u002For growth factors 2. Liver dysfunction: total bilirubin, serum glutamic oxaloacetic transaminase (SGOT; aspartate aminotransferase \\[AST\\]) and\u002For serum glutamic-pyruvic transaminase (SGPT; alanine aminotransferase \\[ALT\\]) \\>1.5 × upper normal limit (UNL); 3. Inadequate renal function: creatinine \\>1.5 × UNL, or eGFR \\\u003C40 mL\u002Fmin; 4. Any Grade 3 or greater toxicity experienced during treatment with prior ARSI; 5. Severe, active co-morbidity defined as follows:\n\n  1. Myocardial infarction within 6 months prior to date of enrollment.\n  2. Current severe or unstable angina.\n  3. New York Heart Association Functional Classification III\u002FIV. (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n  4. Severe chronic obstructive or other pulmonary disease with hypoxemia at rest (requires supplementary oxygen, symptoms due to hypoxemia).\n  5. History of any condition that in the opinion of the investigator, would preclude participation in this study.\n\n     6\\. Known liver metastases based on conventional imaging (i.e., abdominal CT and\u002For MR).\n\n     7\\. Known brain, leptomeningeal or epidural metastases (unless treated, well controlled, and not requiring steroidal therapy for at least 3 months).\n\n     8\\. Major surgery (other than diagnostic surgery), open biopsy, or significant traumatic injury, ≤28 days prior to the date of signing informed consent. Subject must have completely recovered from surgery.\n\n     9\\. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.\n\n     10\\. Treatment of PCa with radiation therapy or surgery ≤28 days prior to the Cycle 1 Day 1.\n\n     11\\. Prior therapy with a hypoxic cytotoxin. 12. HIV-infected patients with detectable viral load and\u002For on effective anti-retroviral therapy (ART) with undetectable viral load for less than 6 months. Note: HIV testing is not required for eligibility for this protocol. Drug-drug interactions with ART occur via many mechanisms, with cytochrome P450 CYP3A4-mediated interactions being the most common. Patients who are using concurrent strong or moderate CYP3A4 inhibitors (e.g., ritonavir, cobicistat) or strong or moderate CYP3A4 inducers must be switched to an alternate effective ART regimen ≥4 weeks before study enrollment or should be excluded from the study if their regimen cannot be altered.\n\n     13\\. Active infection with hepatitis B or hepatitis C (i.e., detectable viral load) with or without active treatment in patients with previously known infection. Note: Only Hepatitis B testing is required for eligibility for this protocol as per standard practice prior to systemic therapy.\n\n     14\\. Subjects who have exhibited allergic reactions to a structural compound similar to evofosfamide or the drug product excipients.\n\n     15\\. Subjects who are taking medications that prolong QT interval and have a risk of Torsades de Pointes (see Appendix A).\n\n     16\\. Subjects with a QTc interval calculated according to Fridericia formula (QTC = QT \u002F RR1\u002F3) of \\>450 msec based on screening electrocardiogram (ECG).\n\n     17\\. Subjects with a history of long QT syndrome. 18. Subjects taking a medication that is a moderate or strong inhibitor or inducer of CYP3A4within 14 days or 5 half-lives (whichever is longer) prior to signing of ICF. (see Appendix B).\n\n     19\\. Subjects taking a medication that is a sensitive substrate or substrates with a narrow therapeutic index of CYP3A4, CYP2D6, or CYP2C9 (see Appendix C).\n\n     20\\. Any other significant concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this trial.\n\n     21\\. Unwillingness or inability to comply with the study protocol for any reason.",{"count":247,"type":20},35,[72],"This is a single-institution, single-arm, open-label Phase 2 trial evaluating evofosfamide in subjects with M1 CRPC who fail first-line ARSIs. In those progressing after second-line Docetaxel or deemed ineligible to it, the use of alternate ARSI remains the most common line of therapy in our Province, in keeping with recent international recommendations. After baseline molecular imaging (PSMA and fluorodeoxyglucose (FDG) PET\u002FCT), prior to evofosfamide initiation, subjects will be encouraged to undergo biopsy of a dominant lesion: FDG-, PSMA-uptake and\u002For conventional imaging determined (in order, and according to feasibility). Subjects will then receive the alternate ARSI (i.e., different from the one received in first line) as per current standard practice and Provincial drug plan coverage. Additionally, subjects will receive combinatorial evofosfamide at a dose of 480 mg\u002Fm2 intravenously (IV) over 60 minutes on Days 1, 8 and 15 of every 28-day cycle. Therapy will continue until disease progression, unacceptable toxicity as a result of evofosfamide, or subject withdrawal. Assessments during evofosfamide treatment will include history, physical exam, and blood tests at each monthly visit to monitor for toxicity. Response and progression will be evaluated by whole-body PSMA PET\u002FCT scan every 8 weeks (± 3 days) and determined using (PE)RECIST v1.1 criteria. PSA, NE markers (e.g., Serum CHGA, NSE), organ function tests (e.g., liver, kidney) and investigational liquid biopsy samples will be followed every cycle (monthly). FDG PET\u002FCT will be performed at baseline, at 6-10 weeks from the date of signing the informed consent form (ICF), and upon progression, irrespective of treatment discontinuation or initiation of another therapy. Subjects will be followed for survival endpoints following completion of this study treatment until death.",[251],"Castration Resistant Prostate Cancer",[41,251,253,254],"ARSIs","androgen receptor signal inhibitors","2026-01-27",{"date":257,"type":53},"2026-01-28",{"date":259,"type":20},"2026-05-27",{"date":261,"type":20},"2030-05-27",{"name":263,"class":142},"University Health Network, Toronto",{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":21,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":143},"100564972","phase-1-gz17-602-in-advanced-crpc-after-progression-on-anti-androgen-therapy-100564972","NCT06636123","GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy","GZ17-6.02 in Advanced Castration-Resistant Prostate Cancer (CRPC) After Progression on Anti-Androgen Therapy","Inclusion Criteria:\n\n* Patients diagnosed with prostate cancer and treated with androgen deprivation therapy (ADT) and at least one androgen receptor pathway inhibitor (ARPI) (eg, abiraterone, enzalutamide, apalutamide or darolutamide). Previous prostate-specific membrane antigen (PSMA)-targeted therapy or cytotoxic chemotherapy is allowed but not required.\n* Androgen levels ≤50 ng\u002FdL (≤1.73 nmol\u002FL).\n* Disease progression following ADT and ARPI treatment described\n* PSA progression over 2 assessments, defined as rising PSA values from 2 consecutive assessments with an interval of at least 7 days between assessments. PSA levels prior to study enrollment are considered and appropriate for inclusion.\n* Measurable disease by RECIST v1.1 on chest\u002Fabdomen\u002Fpelvis CT or evaluable disease observed on bone scan.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2\n* Appropriate hepatic function defined by a total bilirubin (TBL) ≤1.5 × the upper limit of normal (ULN), alanine aminotransferase (ALT) AND aspartate aminotransferase (AST) ≤3 × ULN at screening.\n* Appropriate kidney function defined by calculated or actual creatinine clearance ≥30 mL\u002Fmin\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3.\n* Platelets ≥100,000 cells\u002Fmm3.\n* Serum hemoglobin level ≥8 g\u002FdL.\n* Agree to not donate blood or sperm during the study and for 90 days after the last dose of study treatment.\n* Patients with sexual partners of childbearing potential must agree to use highly effective methods of contraception throughout the study\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Any investigational agent:\n\nwithin 4 weeks OR within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, before initiating study treatment.\n\n* Low PSA (≤10 ng\u002FmL) at initial presentation (before ADT or at symptomatic progression in the castrate setting) plus high volume (≥20) bone metastases.\n* Simultaneous enrollment in any other cancer treatment interventional clinical trial.\n* Active, uncontrolled diarrhea leading to dehydration or electrolyte disturbances not controlled with oral repletion.\n* Grade ≥3 uncontrolled infection.\n* Major surgery (in the opinion of the treating investigator) ≤3 weeks before initiating study treatment.\n* Not having fully recovered to a grade of 1 or lower from any surgery-related adverse effects within the 3 weeks preceding the start of the study treatment.\n* Small cell, anaplastic, or neuroendocrine component.\n* Known active brain metastasis.\n* Known active leptomeningeal disease.\n* Planned ongoing treatment with other drugs thought to potentially have adverse interactions with either of the medications included in the study treatment must be discontinued ≥2 weeks prior to initiating study treatment unless otherwise noted:\n\n  * Monoamine oxidase inhibitors (MAOI) use; must discontinue use 10 days prior to initiating study therapy.\n  * Strong or moderate CYP1A2, CYP3A4 and CYP2C19 inhibitors.\n  * Rucaparib, Olaparib and Talazoparib, due to their common findings of liver enzyme elevation.\n* Inability to swallow medication.\n* Known hypersensitivity to GZ17-6.02 components (curcumin, harmine, and isovanillin) or excipients.\n* Known or suspected malabsorption condition or obstruction.\n* Active untreated hepatitis B or C\" and \"Known liver cirrhosis of any cause, active nonalcoholic steatohepatitis, or nonalcoholic fatty liver disease. Note: no additional testing necessary to confirm\n* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements",{"count":123,"type":20},[23],"The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.",[30],"2026-01-23",{"date":255,"type":53},{"date":278,"type":53},"2025-02-18",{"date":280,"type":20},"2031-10-31",{"name":282,"class":142},"Virginia Commonwealth University",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":21,"phases":292,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":143},"100509891","phase-4-evaluation-of-the-change-in-psma-expression-in-prostate-cancer-in-response-to-hormonal-therapy-100509891","NCT05919329","Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy","Modulation of PSMA Expression in Castration Sensitive and Castration Resistant Prostate Cancer in Response to Hormonal Therapy","Inclusion Criteria:\n\n* Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.\n* Participants must have confirmed prostate adenocarcinoma, histologically, or by combined imaging and biochemical markers.\n* Age \\>= 18 years. Given the nature of the disease in question, only men will be included. Members of all races and ethnic groups will be included.\n* Participants must have sites of prostate cancer showing uptake on an initial PSMA PET scan.\n* Participants are planned to receive hormonal therapy within eight weeks of the initial PSMA PET. The hormonal therapy agents include:\n\n  * For CSPC: GnRH agonists, GnRH antagonists, first-generation antiandrogen (e.g. bicalutamide), or androgen receptor (AR)-targeted agent (e.g. Abiraterone, Enzalutamide, Apalutamide, Darolutamide)\n  * For CRPC: this group of patients are typically on continuous ADT (GnRH agonists or antagonists), which will be continued, and the hormonal therapy they will be started on is an androgen receptor (AR)-targeted agent (e.g. Abiraterone, Enzalutamide, Apalutamide, Darolutamide)\n* Life expectancy \\> 3 months.\n* Cohort 1: Castration resistant prostate cancer with rising PSA (confirmed by two PSA values at least 1 week apart), testosterone \\\u003C 50 ng\u002FdL, on continuous ADT at least 4 months, no AR targeted agent in the prior 4 months.\n* Cohort 2: Castration sensitive prostate cancer with no ADT or AR targeted agents use in the past 12 months, testosterone \\>50 ng\u002FdL\n\nExclusion Criteria:\n\n* Uncontrolled serious infection.\n* Intercurrent illness or condition that would limit compliance with study requirements.\n* Participants who have undergone any cancer treatment other than the hormonal therapy (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the baseline PSMA PET and PSMA PET at day 28.",{"count":291,"type":20},80,[293],"PHASE4","This clinical trial investigates the change in prostate-specific membrane antigen (PSMA) expression in response to hormonal therapy in both, Castration Sensitive Prostate Cancer (CSPC) and Castration Resistant Prostate Cancer (CRPC), and whether this change in PSMA expression changes tumor staging after therapy initiation. Understanding these effects can help define the best timing to perform the PSMA positron emission tomography (PET) relative to the start of therapy.",[251,296,297],"Castration Sensitive Prostate Cancer","Prostate Adenocarcinoma","2025-10-23",{"date":300,"type":53},"2025-10-24",{"date":302,"type":53},"2024-06-25",{"date":304,"type":20},"2030-09-01",{"name":306,"class":142},"OHSU Knight Cancer Institute",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":317,"phases":4,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":169},"100526995","arctic-liquid-biomarkers-in-the-prospective-androgen-receptor-signaling-inhibitors-arsi-resistance-clinical-trials-100526995","NCT06141993","ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials","Clinical Validation of a Circulating Tumor Cell AR Therapy Resistance Assay in Men With Metastatic Castration Resistant Prostate Cancer (ARCTIC)","ARCTIC","Inclusion Criteria:\n\nPatients will be eligible for inclusion in this study only if all of the following criteria apply:\n\n1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Patients with pure small cell\u002Fneuroendocrine tumors of the prostate are not permitted.\n2. Radiographic evidence of metastatic disease by CT, MRI, or PET imaging.\n3. Prior documented disease progression on one potent AR inhibitor (darolutamide, abiraterone, enzalutamide, or apalutamide or combinations of these) in any disease setting (mHSPC, nmCRPC, mCRPC) based on sequential PSA rises or radiographic progression.\n4. Planned therapy with either standard of care enzalutamide and\u002For abiraterone acetate or another potent AR inhibitor (darolutamide, apalutamide if available) within the coming 6 weeks\n5. Castrate levels of testosterone (\\\u003C50 ng\u002Fdl) at most recent assessment and\u002For documented ongoing Androgen Deprivation Therapy.\n6. Evidence of disease progression based on a rising PSA on or following most recent therapy as evidenced by the following:\n\n   1. Consecutive PSA rises at least 2 weeks apart\n   2. Minimum PSA of 1.0 ng\u002Fdl prior to entry\n7. Age \\> 18 years.\n8. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nA patient will not be eligible for inclusion in this study if any of the following criteria apply:\n\n1. History of intercurrent or past medical or psychiatric illness including active stage IV malignancy that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).\n2. Unwillingness to be followed longitudinally for serial CTC biomarker studies.\n3. Life expectancy \\\u003C 6 months\n4. Planned combination therapy with radiation or other systemic therapies other than ADT and bone health agents.",{"count":316,"type":20},120,"OBSERVATIONAL","This study will follow men with metastatic castration resistant prostate cancer throughout their standard of care treatment for their disease to determine if the presence of different genes or proteins can predict which patients respond to the cancer treatment they receive. As tumors grow and begin to spread, they may release cells into patients' bloodstream. These cells are called \"circulating tumor cells\", or CTCs. CTCs can be used to look for differences in \"biomarkers\" (genes or proteins that may change based on how a person is or is not responding to treatment). The purpose of this research study is to learn whether scientists can use biomarkers from CTCs to predict which tumors will respond to certain hormonal therapies. Participants will have blood collected and provide an archival sample from a previous tumor biopsy. The researchers will compare biomarkers from participants who responded well to treatment to those who responded poorly in order to answer the research question.",[182,297,320,30],"Prostate Cancer Metastatic",[322,323,324],"Circulating Tumor Cells (CTC)","Androgen-receptor signaling inhibitors (ARSI)","Metastatic castration resistant prostate cancer (mCRPC)","2025-10-13",{"date":327,"type":53},"2025-10-15",{"date":329,"type":53},"2024-05-13",{"date":331,"type":20},"2027-04",{"name":333,"class":142},"Duke University",{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":21,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":143},"100561042","phase-3-metastasis-directed-therapy-in-oligoprogressive-castration-refractory-prostate-cancer-100561042","NCT06585007","Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer","Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer: a Randomized Phase 3 Trial","MEDCARE","Inclusion Criteria:\n\nParticipants eligible for inclusion in this Trial must meet all the following criteria:\n\n* Written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n* Acinar adenocarcinoma (inclusive neuro-endocrine dedifferentiation).\n* Oligoprogressive disease on conventional imagine within a maximum of 6 weeks prior to randomisation defined as: a maximum of 3 extracranial progressive lesions (pre-existing lesions, the development of new lesions, or both) in any organ. Nodal (N1) disease should be measured in the short axis. Nodes more than 1.5 cm in the short axis are considered pathologic and measurable. Oligoprogression on bone scan is defined as the occurrence of maximal 3 new and\u002For progressive lesions. In case of not unambiguously, additional imaging such as diagnostic magnetic resonance imaging (MRI) or dedicated CT-scan should be performed. Visceral disease reported separately (lung, liver, adrenal, or CNS) and is considered measurable if an individual lesions is more than 1 cm longest dimension.\n\nIn case of locally persistent\u002Frecurrent disease, a diagnostic MRI of the prostate (bed) and\u002For biopsy of the site is recommended. There are two different mCRPC patient groups who are eligible for inclusion in the trial:\n\n1. Patients with oligoprogressive disease with pADT only as ongoing treatment (Type 1).\n2. Patients with oligoprogressive disease with pADT +\u002F- second line systemic therapy. This is both the combination of pADT + ARTA as ongoing treatment or patients who had received docetaxel in the past (Type 2).\n\n   * Castration-refractory disease, defined as testosterone level \\\u003C 50 ng\u002FdL.\n   * Prior treatment of the primary tumor by radiotherapy or surgery. If the primary tumor has not been treated previously, this treatment is obligatory within the trial.\n   * WHO performance 0-2\n   * Age \\>= 18 years old\n   * Absence of psychological, sociological, or geographical condition potentially hampering compliance with study protocol.\n   * Patients must be presented at the multidisciplinary board meeting and the inclusion in the trial needs approval by this board.\n\nExclusion Criteria:\n\n* Ductal adenocarcinoma and small-cell prostate cancer.\n* Serum testosterone level \\> 50 ng\u002Fml.\n* Presence of poly-progressive disease, defined as more than 3 progressive lesions on conventional imaging or nodal and\u002For metastatic lesions on conventional imaging\n* Active malignancy other than prostate cancer that could potentially interfere with the interpretation of this trial.\n* Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible.\n* Spinal bone lesion that is highly symptomatic, neurologically threatening or at risk of fracture.\n* Patients already treated with radionuclides, cabazitaxel or PARP-inhibitors in the past.\n* Patients with progressive disease while receiving docetaxel.\n* Not able to understand the treatment protocol or sign informed consent.",{"count":343,"type":20},246,[73],"Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.",[30,347],"Oligoprogressive","2024-09-04",{"date":350,"type":53},"2024-09-05",{"date":352,"type":53},"2023-12-19",{"date":354,"type":20},"2029-01-20",{"name":356,"class":142},"Universitaire Ziekenhuizen KU Leuven",{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":21,"phases":366,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":143},"100542451","phase-1-targeted-radionuclide-therapy-in-metastatic-prostate-cancer-using-a-new-psma-ligand-radiolabelled-with-terbium-161-161tb-sibudab---dose-identificationescalation-phase-iab-study-100542451","NCT06343038","Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification\u002FEscalation Phase Ia\u002Fb Study","PROGNOSTICS","Inclusion Criteria:\n\n* Consent form signed\n* Male patients with age \\> 18 years\n* Clinical indication for RLT with 177Lu-PSMA-I\\&T (progressive PSMA-positive mCRPC patients after androgen receptor signalling pathway inhibitor and taxan-based chemotherapy or patient unfit for chemotherapy)\n* Patients will be included in Phase Ia while being under active therapy with 177Lu-PSMA-I\\&T (SoC) and after they have completed the first two cycles of 177Lu-PSMA-I\\&T RLT\n* At least 3 measurable tumours on PSMA PET\u002FCT (\\>1.5 cm) with sufficiently intense PSMA uptake (SUVmax\\>20)\n* ECOG Performance status: 0-1\n* Blood parameters: a) Leucocytes ≥ 3 G\u002FL; b) Haemoglobin ≥ 100 g\u002FL; c) Thrombocytes ≥ 100 G\u002FL\n* Estimated glomerular filtration rate (eGFR) \\> 45 ml\u002Fmin\n* Albumin \\> 25 g\u002FL\n* ALT, AST, AP: ≤ 5 times upper standard value\n* Bilirubin ≤ 2 times upper standard value\n* For male patients who are not surgically sterilized (orchiectomy or vasectomy), appropriate contraceptive measures must be taken during RLT and until 4 months after completion of RLT. As acceptable contraceptive count sexual abstinence or double contraceptive methods: hormonal contraceptive (oral, transdermal, implants or injections) in combination with barrier methods (spiral, condom, diaphragm)\n\nExclusion Criteria:\n\n* Prior PSMA-targeted RLT (except for the 2 first cycles in Part Ia)\n* PSMA-negative (or PSMA-negative \u002F FDG-positive) disease\n* Known intolerance against DOTA, DOTAGA, urea-based analogues or against any of the components\u002Fformulation of 177Lu-PSMA-I\\&T or 161Tb-SibuDAB solutions.\n* Ongoing infection at the screening visit or a serious infection in the past 4 weeks\n* Administration of another investigational product in the last 60 days before Visit 1 Day 1\n* Prior or planed administration of a therapeutic radiopharmaceutical during 8 half-lives of the used radio-pharmaceutical's radionuclide, also during the ongoing study\n* Any extensive radiotherapy involving bone marrow over the last 3 months before inclusion to the study\n* Chemotherapy in the last 4 weeks before inclusion\n* Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus \\[HbA1c ≥ 9%\\], uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study. Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and\u002For an uncooperative attitude from the patient.\n* Current history of any malignancy other than prostate cancer within 5 years of enrolment except for fully resected non-melanoma skin cancer",{"count":365,"type":20},25,[23],"Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before.\n\nIn the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time.\n\nThe aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects.\n\nThe performance of different prostate cancer diagnostic methods is also in scope of the study.",[30],[370,371,372,373,374],"Radioligand Therapy","Phase Ia\u002FIb","Circulating Tumour Cells","Biomarkers Development","Voxel-based 3D Dosimetry","2024-08-13",{"date":377,"type":53},"2024-08-14",{"date":379,"type":53},"2024-02-20",{"date":381,"type":20},"2028-06",{"name":383,"class":142},"University Hospital, Basel, Switzerland",{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":21,"phases":393,"briefSummary":394,"conditions":395,"keywords":396,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":405,"locationsCount":169},"100533541","phase-2-disitamab-vedotin-in-the-treatment-with-her2--expression-subjects-with-locally-advanced-or-metastatic-castration-resistant-prostate-cancer-100533541","NCT06227156","Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer","A Multicenter Open Phase II to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Pathology confirmed prostate adenocarcinoma\n3. Locally advanced or metastatic prostate cancer\n4. PCWG3 criteria-compliant prostate cancer progression occurs during androgen deprivation therapy (or bilateral scrotal excision). Progression will be determined based on at least 1 of the following criteria: PSA progression: defined as 2 consecutive increases in PSA, separated by at least 1 week, relative to the previous reference value. If a confirmed PSA increase is the only indicator of progression, then 1 ng\u002FmL is the minimum starting value; Soft tissue progression: defined as an increase of ≥20% in the sum of the diameters of all target lesions (short-axis for lymph node lesions and long-axis for non-lymph node lesions) relative to the sum of the smallest diameters at the start of treatment or the presence of one or more new lesions; Bone lesion progression: defined as the detection of at least two additional new lesions on bone scan.\n5. Serum testosterone level ≤ 50 ng\u002FdL (or ≤ 1.73 nmol\u002FL), prior to the first study drug administration;\n6. Continuous androgen deprivation therapy (ADT) with LHRH agonists or LHRH antagonists or previous bilateral orchiectomy (surgical debridement) during the study period;\n7. Confirmed HER2 expression (IHC 1+, 2+, 3+), HER2 gene amplification, or HER2 gene mutation;\n8. Subjects were able to provide paraffin blocks or at least 5 paraffin embedded sections (white pieces) for HER2 detection, and the presence of HER2 expression was confirmed by central laboratory tests (immunohistochemistry 1+, 2+, 3+)；\n9. Previous medical androgen deprivation therapy (or bilateral scrotal excision) and new hormone therapy (e.g. abiraterone, enzalutamide) and have developed disease progression\n10. The following criteria should be met within 7 days prior to the first study dose:\n\n    1. haemoglobin ≥ 9 g\u002FdL;\n    2. absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL;\n    3. platelet count ≥ 100 × 109\u002FL;\n    4. serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN);\n    5. without liver metastasis, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × ULN; with liver metastasis, alanine aminotransferase and aspartate aminotransferase ≤ 5 × ULN;;\n    6. albumin (ALB) ≥ 25 g\u002FL;\n    7. blood creatinine ≤ 1.5 × ULN, or calculated according to the Cockcroft-Gault formula, creatinine clearance (CrCl) ≥ 50 mL\u002Fmin;\n    8. left ventricular ejection fraction (LVEF) ≥ 50%;\n11. ECOG Physical Status Score of 0-1\n12. Expected survival ≥ 6 months\n13. Subjects whose spouses are of childbearing age must agree to use contraception during the study and for 6 months after the last dose; sperm donation is not permitted during the study and for 6 months after the last dose\n14. Ability to understand and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Systematic chemotherapy, novel hormone therapy, targeted therapy, immunotherapy, or other antitumor therapy (including 5-alpha reductase inhibitors, oestrogens, and medroxyprogesterone, etc.)was administered prior to the initial study drug, and treatment ended within 5 half-lives (or 2 weeks, whichever is shorter) of the initial study drug. Except maintenance castration therapy (LHRH agonists or LHRH antagonists) or bone metastasis therapy(e.g., denosumab, zoledronic acid); In the first study, Chinese medicines with anti-tumor indications were used 2 weeks before administration.\n2. Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis (subjects who have been treated for brain metastases may be enrolled in this study provided they have stable disease \\[no evidence of progression as determined by imaging for at least 4 weeks prior to study dosing and and all neurological symptoms have fully recovered\\], there is no evidence of new or enlarging brain metastases, and discontinuation of steroid therapy at least 7 days prior to the first dose of the trial treatment. (This exception does not include carcinomatous meningitis, which should be excluded regardless of whether it is clinically stable or not).\n3. Has received anti-HER2 therapy ;\n4. Major surgery, systemic radiotherapy or biologic therapy within 4 weeks prior to first study drug administration, or minor surgery or local radiotherapy within 1 week prior to enrollment;\n5. Toxicity due to prior antineoplastic therapy that has not recovered to Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) Grade 1 or below, with the exception of alopecia and abnormalities in laboratory tests or toxicity associated with LHRH agonists or LHRH antagonists that are not considered by the investigator to pose a safety risk;\n6. Known allergic reactions to components of the study treatment or its analogues\n7. Diagnosis of other malignancies that are expected to affect life expectancy or may interfere with disease assessment. Except for cured non-melanoma skin cancer and superficial bladder cancer\n8. Severe and\u002For persistent infection within 14 days prior to starting the study drug\n9. Serum virological tests: positive HBsAg test result with a positive HBV DNA copy number; positive HCVAb test result; positive HIVAb test result;\n10. Known serious cardiovascular disease, including any of the following: myocardial infarction, thrombotic event, or unstable angina pectoris in the past 3 months; chronic heart failure, New York Heart Association (NYHA) class II or higher; presence of unstable arrhythmia; uncontrolled hypertension;\n11. Combined grade 2 and higher (CTCAE version 5.0) peripheral neuropathy\n12. Presence of other systemic diseases that, in the judgement of the investigator, are not under stable control, including diabetes mellitus, liver cirrhosis, pneumonitis, and obstructive pulmonary disease;\n13. In the judgement of the investigator, there were other circumstances that made participation in the study unsuitable.",{"count":392,"type":20},40,[72],"The purpose of this study is to evaluate the effectiveness of Disitamab Vedotin in the treatment of subjects with locally advanced or metastatic castration-resistant prostate cancer.",[30],[397,398],"Metastatic Castration-resistant prostate cancer.","HER2- expression","2024-05-21",{"date":401,"type":53},"2024-05-23",{"date":403,"type":53},"2024-04-08",{"date":81,"type":20},{"name":406,"class":60},"RemeGen Co., Ltd.",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":21,"phases":415,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":143},"100426891","stereotactic-ablative-radiation-therapy-for-abiraterone-resistant-oligoprogressive-metastatic-prostate-cancer-100426891","NCT04838899","Stereotactic Ablative Radiation Therapy for Abiraterone-Resistant, Oligoprogressive Metastatic Prostate Cancer","Stereotactic Ablative Radiotherapy for Oligoprogressive Metastatic Castration-Resistant Prostate Cancer During Abiraterone Therapy","Inclusion Criteria:\n\n* ECOG performance status 0-1.\n* Histologic confirmation of prostate adenocarcinoma.\n* Documentation of metastatic, castration-resistant prostate cancer.\n* Patient being treated with abiraterone.\n* Evidence of oligoprogression (according to RECIST \\[V1.1\\] and\u002For Prostate Cancer Working Group criteria \\[PCWG3\\], as applicable), applying any of the following: (i) ≤ 5 metastatic lesions progressing on conventional imaging (≤ 3 progressing metastases in any one organ system) while all other metastases are controlled or responding; (ii) PSA progression only, but in the setting of oligometastases (≤ 5 metastatic lesions seen on imaging, with ≤ 3 metastases in any one organ system); in this setting, all metastases will be irradiated.\n* All metastases of interest amenable to SABR.\n\nExclusion Criteria:\n\n* Patients presenting with unequivocal clinical progression, defined as one of the following: (i) cancer pain requiring the initiation of opioid therapy; (ii) immediate need for cytotoxic chemotherapy as per treating physician's discretion; or (iii) deterioration of performance status to grade ≥ 3 according to ECOG.\n* Evidence of spinal cord compression.\n* Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.",{"count":123,"type":20},[416],"NA","There is increasing worldwide interest in exploring stereotactic ablative body radiotherapy (SABR) for treating metastases in men with prostate cancer, including for the treatment of oligoprogressive metastases. The latter applies to a situation whereby patients with widespread metastases undergoing systemic therapy present with a solitary or a few metastatic tumors that progress, while all other metastases are stable or responding. The usual practice would be to change systemic therapy at this point, but another approach is to locally ablate the \"rogue\" metastases and continue the same systemic therapy. SABR used in this scenario may delay the need to switch to another line of systemic therapy and improve progression-free survival while patients stay on the same systemic therapy.",[347,419],"Castration-Resistant Prostate Cancer","2024-04-10",{"date":422,"type":53},"2024-04-12",{"date":424,"type":53},"2016-07-16",{"date":426,"type":20},"2026-12-31",{"name":428,"class":142},"Sunnybrook Health Sciences Centre",{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":317,"phases":4,"briefSummary":438,"conditions":439,"keywords":440,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":143},"100540810","response-evaluation-of-cancer-therapeutics-in-metastatic-castration-resistant-prostate-cancer-to-the-bone-100540810","NCT06321679","Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone","Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer (mCRPC) to the Bone: A Whole Body MRI Study","RESPECT","Inclusion Criteria:\n\n* Histological diagnosis of castration-resistant prostate cancer,\n* Single or multiple bone metastases,\n* Life expectancy of over 6 months,\n* No current active malignancy other than prostate cancer,\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Absolute contraindication to WB-MRI, CT or BS,\n* Radical treatment of sole site of metastatic disease (e.g. Cyberknife to solitary metastatic lesion),\n* Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions are to be discussed with the patient as part of the informed consent process.",{"count":392,"type":20},"This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone.\n\nThis is a monocentric, prospective observational study.",[30],[441,442],"castration-resistant prostate cancer","whole body magnetic resonance imaging","2024-03-13",{"date":445,"type":53},"2024-03-20",{"date":447,"type":53},"2020-07-03",{"date":449,"type":20},"2027-12-31",{"name":451,"class":142},"European Institute of Oncology"]