[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"castration-resistant-metastatic-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:castration-resistant-metastatic-prostate-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,78,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100640310","phase-1-a-study-of-225acac-aky-2519-in-patients-with-metastatic-castration-resistant-prostate-cancer-100640310",false,"NCT07581184","A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer","BActinium-1: A Phase 1b, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Intravenous Administration of B7-H3 Radiopharmaceutical ([225Ac]Ac-AKY-2519) in Metastatic Castration-Resistant Prostate Cancer","BActinium-1","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologic or cytologic confirmation of prostatic adenocarcinoma\n* ECOG Performance Status of 0 or 1\n* Adequate end-organ function\n* Ability to give informed consent and comply with study requirements\n* Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids\n* Castrate levels of serum testosterone (\\\u003C 50 ng\u002FdL)\n* Documented disease progression on most recent prior line of therapy, either by PSA or imaging-based progression\n* Cohort B: Received 2 or more prior doses of 177Lu-PSMA-617 (PLUVICTO)\n\nExclusion Criteria:\n\n* Prior treatment with more than 2 Androgen receptor pathway inhibitors (ARPIs) and\u002For more than 1 taxane-based therapy in the mCRPC setting\n* Prior treatment with a targeted radiotherapy\n\n  o Exception: Cohort B is required to have had at least 2 prior doses of 177Lu-PSMA-617 (PLUVICTO)\n* Prior treatment with a B7-H3 targeted therapy\n* Received an investigational agent within the previous 28 days\n* Impaired cardiac function or clinically significant cardiac disease\n* Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity","MALE","18 Years",{"count":20,"type":21},138,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a Phase 1b, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \\[64Cu\\]Cu-AKY-2519 and\u002For \\[225Ac\\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \\[225Ac\\]Ac-AKY-2519 in participants with metastatic castration-resistant prostate cancer (mCRPC) with and without prior exposure to 177Lu-PSMA-617 (PLUVICTO™).",[27,28,29,30,31],"Castration Resistant Metastatic Prostate Cancer","Prostate Cancer","mCRPC (Metastatic Castration-resistant Prostate Cancer)","mCRPC","B7H3",[33,15,34,35],"AKY-2519","AKY-2519-01","B7-H3","RECRUITING","2026-05-06",{"date":39,"type":40},"2026-05-12","ACTUAL",{"date":42,"type":21},"2026-07",{"date":44,"type":21},"2032-06",{"name":46,"class":47},"Aktis Oncology, Inc.","INDUSTRY",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100390380","phase-2-sequential-testosterone-and-enzalutamide-prevents-unfavorable-progression-100390380","NCT04363164","Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression","A Randomized Phase II Study Comparing Sequential High Dose Testosterone and Enzalutamide to Enzalutamide Alone in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer","Inclusion Criteria:\n\n1. ECOG Performance status ≤2.\n2. Age ≥18 years.\n3. Histologically-confirmed adenocarcinoma of the prostate.\n4. Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist\u002Fantagonist).\n5. Documented castrate level of serum testosterone (\\\u003C50 ng\u002Fdl).\n6. Metastatic disease radiographically documented by CT or bone scan.\n7. Must have had disease progression while on combination of abiraterone acetate plus ADT either given concurrently or sequentially based on:\n\n   * PSA progression defined as an increase in PSA, as determined by 2 separate measurements taken at least 1 week apart And\u002F Or\n   * Radiographic disease progression, based on RECIST 1.1 in patients with measurable soft tissue lesions or PCWG3 for patients with bone disease\n8. Screening PSA must be ≥ 1.0 ng\u002FmL.\n9. Patients with soft tissue lesion amenable to biopsy must agree to biopsy collection pre-treatment and at a defined point on treatment to perform tumor tissue analysis.\n10. No prior treatment with enzalutamide, apalutamide, darolutamide, or other investigational AR targeted treatment is allowed.\n11. Prior treatment with testosterone is allowed.\n12. Prior treatment with one chemotherapy regimen with docetaxel (≤ 6 doses) for hormonesensitive prostate cancer is allowed.\n13. Prior treatment with Provenge vaccine and 223Radium (Xofigo) is allowed if \\>4 weeks from last dose.\n14. Patients must be withdrawn from abiraterone for ≥ 2 weeks.\n15. Attempts must be made to wean patients off prednisone prior to starting therapy. Patients who cannot be weaned due to symptoms may continue on lowest dose of prednisone achieved during weaning period.\n16. Acceptable liver function:\n\n    1. Bilirubin \\\u003C 2.5 times institutional upper limit of normal (ULN)\n    2. AST (SGOT) and ALT (SGPT) \\\u003C 2.5 times ULN\n17. Acceptable renal function:\n\n    a. Serum creatinine \\\u003C 2.5 times ULN\n18. Acceptable hematologic status:\n\n    1. Absolute neutrophil count (ANC) ≥ 1500 cells\u002Fmm3 (1.5 ×109\u002FL)\n    2. Platelet count ≥ 100,000 platelet\u002Fmm3 (100 ×109\u002FL)\n    3. Hemoglobin ≥ 8 g\u002FdL.\n19. At least 4 weeks since prior radiation or chemotherapy.\n20. Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Pain due to metastatic prostate cancer requiring treatment intervention with pain medication.\n2. ECOG Performance status ≥3\n3. Prior treatment with enzalutamide is prohibited.\n4. Prior chemotherapy with docetaxel or cabazitaxel for castration resistant prostate cancer is prohibited.\n5. Requires urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate cancer or benign prostatic hyperplasia (BPH). Patients with indwelling Foley or suprapubic catheter for obstructive symptoms are eligible.\n6. Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g. femoral metastases with concern over fracture risk, severe and extensive spinal metastases with concern over spinal cord compression, extensive liver metastases).\n7. Evidence of serious and\u002For unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.\n8. Active uncontrolled infection, including known history of HIV\u002FAIDS or hepatitis B or C.\n9. Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements as determined by the investigator.\n10. Patients receiving anticoagulation therapy with warfarin, rivaroxaban, or apixaban are not eligible for study. \\[Patients on enoxaparin eligible for study. Patients on warfarin, rivaroxaban,or apixaban, who can be transitioned to enoxaparin prior to starting study treatments will be eligible\\].\n11. Patients are excluded with prior history of a thromboembolic event within the last 12 months that are not being treated with systemic anticoagulation.\n12. Hematocrit \\>51%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure \\[per Endocrine Society Clinical Practice Guidelines (34)\\]\n13. Patients allergic to sesame seed oil or cottonseed oil are excluded.\n14. Major surgery (eg, requiring general anesthesia) within 3 weeks before screening, or has not fully recovered from prior surgery (ie, unhealed wound). Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate.","90 Years",{"count":58,"type":21},150,[60],"PHASE2","Asymptomatic men without pain due to prostate cancer progressing with metastatic CRPC after treatment with combination or sequential ADT + Abi will be treated on a randomized, open label study to determine if sequential treatment with high dose T and Enza will improve primary and secondary objectives vs. continuous Enza as standard therapy.",[27],[64,65,66],"Testosterone","Enzalutamide","Androgen Deprivation Therapy (ADT)","2026-03-31",{"date":69,"type":40},"2026-04-06",{"date":71,"type":40},"2020-08-19",{"date":73,"type":21},"2027-07",{"name":75,"class":76},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",6,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100562256","intrinsic-validity-of-molecular-markers-detection-on-tissular-tumoral-dna-to-predict-the-efficacy-of-177lutetium-psma-617-lu-psma-treatment-for-castration-resistant-metastatic-prostate-cancer-100562256","NCT06600802","Intrinsic Validity of Molecular Marker(s) Detection on Tissular Tumoral DNA to Predict the Efficacy of 177Lutetium-PSMA-617 (Lu-PSMA) Treatment for Castration-resistant Metastatic Prostate Cancer","Intrinsic Validity of Molecular Marker(s) Detection on Tissular Tumoral DNA to Predict the Efficacy of 177Lutetium-PSMA-617 (Lu-PSMA) Treatment for Castration-resistant Metastatic Prostate Cancer (PSMA-PRED)","PSMA-PRED","Inclusion Criteria:\n\n* Male \\>18 years of age\n* ECOG ≤ 2\n* Patient with histologically confirmed of metastatic castration resistant prostatic adenocarcinoma and with tumor biological material available (prostatic biopsies or prostatectomy)\n* Patient who received at least one taxane line and a second generation hormone therapy line\n* Patient receiving androgen deprivation therapy with serum testosterone \\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL or having undergone surgical castration\n* Progressive mCRPC based based on at least 1 of the following criteria :\n\n  * Serum or plasma PSA progression defined as 2 consecutive increases in PSA measured at least 1 week prior. The minimal start value is 2.0 ng\u002FmL ; 1,0 ng\u002FmL is the minimal start value if confirmed increase in PSA is the only indication of progress\n  * Soft-tissue progression by RECIST 1.1 criteria\n  * Progression of bone disease : two new lesions ; only the positivity of bone scan defines metastatic bone disease, according to PCWG3 criteria.\n* Patients with at least one metastasis, bone and\u002For soft tissue and\u002For visceral, documented by the following methods in the 43 days prior to inclusion :\n\n  * Bone metastasis (regardless of location) highlighted by bone scan AND\u002FOR\n  * Lymph nodes metastasis, regardless of size and location; if the metastasis are only lymph nodes, the short axis of at least one node should be at least 15 mm AND outside the pelvis ; AND\u002FOR\n  * Visceral metastasis, regardless of size and location; a history of visceral metastasis at any time prior to randomization should be encoded as the presence of visceral metastasis at baseline (i.e., a patient with visceral metastasis prior ADT introduction which are disappeared at baseline will be counted as having visceral metastasis and will be considered to have a high tumor volume during stratification)\n* Patient with Lu-PSMA treatment indication, confirmed by PET 68Ga-PSMA-11. Eligibility for 68Ga-PSMA-11 PET is defined as:\n\n  * At least one lesion with a binding intensity greater than that of the liver parenchyma (definition of positivity),\n  * All lymph node lesions larger than 25 mm in the short axis must be positive on PSMA PET\n  * All bone metastases with a soft tissue component ≥ 10 mm in the largest diameter must be positive on PSMA-PET\n  * All solid organ metastases (e.g., lung, liver, adrenal glands, etc.) ≥ 10 mm in the largest diameter must be positive on PSMA-PET.\n* Adequate organ function :\n\n  * Bone marrow reserve :\n\n    * Absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL\n    * Platelets ≥ 100 x 10\\^9\u002FL.\n    * Hemoglobin ≥ 9 g\u002FdL\n  * Hepatic function :\n\n    * Total bilirubin ≤ 2 x the upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤ 3 x ULN is permitted.\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases.\n    * Albumin \\> 2.5 g\u002FdL\n  * Renal function : Glomerular Filtration Rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73m2 according to MDRD equation.\n* Obtaining the patient's free and informed consent\n* Social security scheme or beneficiary.\n\nExclusion Criteria :\n\n* Continuation of second-generation hormone therapy Patient\n* Other cancer in the last 3 years likely to change life expectancy or interfere with the assessment of the disease\n* Protected adult\n* History of somatic or psychiatric illness\u002Fcondition that may interfere with study objectives and evaluations\n* Patient unable to understand and comply with study instructions and requirements\n* ECOG \\> 2\n* Dilation of pyelocalicial cavities not previously supported\n* Obstruction of bladder discharge or uncontrollable and simultaneous urinary incontinence\n* Symptomatic spinal cord compression or clinical or radiological findings indicating imminent spinal cord compression\n* Fractured risk of bone damage\n* Active and symptomatic brain injury\n* Concurrent participation in a therapeutic trial and administration of any investigational agent within 28 days of inclusion\n* Metastatic tumor tissue as the only material available for prostate cancer diagnosis\n* Previous treatment with any of the following in the 6 months prior to inclusion : Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-cyclic irradiation\n* Previous treatment with radioligands targeting PSMA\n* Known hypersensitivity to one of the study treatments or its excipients or similar class drugs\n* Transfusion or use of bone marrow stimulating agents for the sole purpose of making a participant eligible for inclusion in the study",{"count":87,"type":21},120,[89],"NA","Prostate cancer is the most common cancer in men. Its incidence is rising as the population ages. In the localized stage, the 5-year overall survival rate (OS) is 98%. Metastatic progression and resistance to castration have a negative impact on prognosis. Despite recent advances in management, the 5-year OS is around 30%. Therapeutic advances in this indication have been made mainly by the use of taxanes and second-generation hormone therapy. These treatments have improved OS and progression-free survival (PFS). They are now used as standard therapy.\n\nMore recently, the Phase III VISION trial confirmed the improvement in OS and radiological PFS achieved by treatment with the radioligand 177Lutetium-PSMA-617 (Lu-PSMA) in patients with advanced metastatic castration-resistant prostate cancer (mCRPC).\n\nThis treatment is currently available in early access in France. Despite encouraging results, 40% of patients will not respond to Lu-PSMA, and there are currently no validated predictive factors. Studies are currently on going, but the identification of biomarkers seems necessary to better stratify risk in these patients.\n\nNumerous tissue prognostic tests based on molecular characteristics or cell proliferation are emerging with this in mind. At present, molecular profiling is not a routine technique for prostate cancer, as it is for other solid cancers. At an early stage, the Decipher® Genomic classification tool has shown prognostic utility independently of therapeutic and clinico-pathological data.\n\nAccording to recent studies, methylome analysis would enable the subdivision of mCRPCs and could help identify new therapeutic targets.\n\nIn the metastatic phase, certain molecular abnormalities involving DNA repair genes are predictive of response to PARP inhibitors.\n\nMolecular analysis (mutations, copy number alterations, gene expression, DNA methylation) could therefore be useful in optimizing the management of mCRPC patients treated with Lu-PSMA.\n\nIf reliable molecular abnormalities are identified on tissue, a diagnostic technique based on circulating tumor DNA (ctDNA) analysis will be useful in decision-making for these patients. A biological collection will therefore be created during the course of this study, with a view to using ctDNA analysis in subsequent research.",[92,93],"Castration-resistant Metastatic Prostate Cancer","Treated by 177Lutetium-PSMA-617 (Lu-PSMA)",[30,95,96,97,98],"Lu-PSMA","biomarkers","response","prediction","2025-12-26",{"date":101,"type":40},"2025-12-31",{"date":103,"type":40},"2024-10-08",{"date":105,"type":21},"2034-06-30",{"name":107,"class":76},"Centre Jean Perrin",5,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":48},"100595888","phase-2-the-impact-of-metastatic-directed-radiotherapy-mdrt-on-oligoprogressive-castration-resistant-prostate-cancer-crpc-100595888","NCT07038304","The Impact of Metastatic Directed Radiotherapy (MDRT) on Oligoprogressive Castration Resistant Prostate Cancer (CRPC)","Oligometastatic Directed Radiotherapy for Patients With Castration Resistant Prostate Cancer","OLYMPIAN","Inclusion Criteria:\n\n* Adenocarcinoma of the prostate.\n* mCRPC setting, with testosterone level \\\u003C 50 ng\u002Fdl or 1.7 nmol\u002Fl.\n* Oligoprogressive disease diagnosed on PSMAscan; defined as the progression of pre-existing metastatic disease, and\u002For the appearance of new metastases and\u002For the appearance of a local relapse with a maximum of 3 lesions in total.\n* Patients currently treated with ADT, whether combined with another systemic treatment such as ARTA, chemotherapy.\n* For patients treated with chemotherapy, the course should be completed or stopped before start MORT - In case of treatment with ARTA, a minimal of 3 months response (PSA or clinical response).\n* WHO performance status 0-2.\n* Age \\> = 18 years old.\n* Patiënt should be presented at the multidisciplinary tumor board of the local hospital in which the therapy will be given.\n* Before patiënt registration, written informed consent must be given according to ICH\u002FGCO and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Serum testosterone level \\> 50 ng\u002Fml or \\> 1.7 nmol\u002Fl.\n* Presence of more than 3 progressive\u002Fnew metastatic lesions and\u002For local recurrence (which counts for 1 lesion).\n* Active malignancy other than prostate cancer that can potentially interfere with the interpretation of the trial, except non-melanoma skin cancer or non-invasive urothelial cell carcinoma.\n* Local recurrence in the prostate after previous radiotherapy\n* Previous treatments (RT, surgery) or comorbidities making new treatment with MDRT impossible.\n* Disorder precluding understanding of trial Information or informed consent or signing informed consent.\n* Evidence of PSMA-negative disease.",{"count":118,"type":21},35,[60],"In patients with metastatic prostate cancer (PCa) who receive androgen deprivation therapy (ADT), the sensitivity to castration will eventually disappear due to the selection of castration-refractory clones. This will lead to the stage of metastatic castration-refractory prostate can-cer (mCRPC), which is incurable and results in a median overall survival of 2-3 years.\n\nTreatment options for patients with mCRPC include several systemic agents, such as andro-gen receptor-targeted agents (ARTA), chemotherapy (docetaxel, cabazitaxel) and bone-targeting agents (radium- 223). Clinical progression and, to a lesser extent, biochemical pro-gression traditionally imply a switch to the next line systemic treatment (NEST). Within patients with mCRPC, there is a subgroup showing oligo-progression, defined as the progression of up to 3 lesions, including both metastatic and\u002For local relapse. Oligoprogression reflects a heterogeneous treatment response, which, in turn, reflects the heterogeneity of the clonogenic cells that give rise to mCRPC. Retrospective studies suggest that metastasis-directed radiotherapy (MDRT) to these oligoprogressive lesions delayed the need for NEST. Recently, promising results were published on the use of MDRT in the oligopro-gressive mCRPC (omCRPC) setting, with a NEST-free survival (NEST-FS) of 21 months in well selected patients. Currently, in The Netherlands, patients with omCRPC are frequently referred and treated with MDRT, but a clear treatment protocol and inclusion\u002Fselection criteria are missing. Moreover, the exact benefit of MDRT in patients with omCRPC remains unclear, as prospective evi-dence for MDRT in omCRPC is lacking.",[122,123,27,124],"Prostate Cancer (Adenocarcinoma)","OligoProgressive Metastatic Disease","Radiotherapy","2025-06-17",{"date":127,"type":40},"2025-06-26",{"date":129,"type":40},"2025-01-03",{"date":131,"type":21},"2029-01-03",{"name":133,"class":76},"University Medical Center Groningen"]