[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-hormone-sensitive-prostate-cancer-mhspc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-hormone-sensitive-prostate-cancer-mhspc":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,43,69,99,121,144,174,203,223,245,279,307,338,362,391],{"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":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100603775","phase-1-study-evaluating-the-safety-tolerability-and-efficacy-of-xaluritamig-in-combination-with-androgen-receptor-pathway-inhibitors-in-participants-with-metastatic-hormone-sensitive-prostate-cancer-100603775",false,"NCT07140900","Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer","A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer","Inclusion Criteria:\n\n* Participants must have histological, pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.\n* Participants must have at the time of diagnosis:\n\n  * De novo (synchronous) mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer, AND started ADT (LHRH agonist\u002Fantagonist or orchiectomy) with or without ARPI (defined as abiraterone OR darolutamide) as SOC, first treatment with ADT should be no longer than 12 weeks before screening. Prior docetaxel treatment is not permitted.\n* Participants must have at the time of diagnosis:\n\n  * High-volume metastatic disease defined as presence of visceral metastasis or metastases, and\u002For ≥ 4 bone metastases with at least one outside of the vertebral column and pelvis.\n* Documented metastatic disease either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast enhanced abdominal\u002Fpelvic\u002Fchest computed tomography (CT) or magnetic resonance imaging (MRI) scan.\n* No documented PSA progression following the initial PSA nadir after starting ADT.\n\nExclusion Criteria:\n\n* Prior history of central nervous system (CNS) metastases. Note: Participants with asymptomatic and clinically stable dural metastases are eligible.\n* Unresolved toxicities from prior anti-tumor therapy (excluding those related to ongoing ADT and ARPI) not having resolved to Common Terminology Criteria for Adverse events (CTCAE) version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.\n* Autoimmune disease requiring systemic immunosuppression within the past 2 years.\n* Participant with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active or systemic infection within 7 days prior to the first dose of study treatment.\n* Prior six-transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.\n* Prior radioligand therapy (RLT), poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, cytotoxic chemotherapy, aminoglutethimide or ketoconazole for prostate cancer, or any prior systemic biologic therapy, including immunotherapy for prostate cancer.\n* Prior enzalutamide or apalutamide within 15 days prior to enrolment.\n* Requirement for chronic systemic corticosteroid therapy (prednisone dose greater than 10 mg per day or local equivalent) or any other immunosuppressive therapies (including anti TNFα therapies) unless stopped (with adequate tapering) within 7 days prior to dosing.\n* Prior radiotherapy to all metastatic sites of disease. Radiotherapy to some sites of metastatic disease for palliation will be permitted.","MALE","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.",[26],"Metastatic Hormone-sensitive Prostate Cancer (mHSPC)",[28,29],"Prostate cancer","Xaluritamig","RECRUITING","2026-07-01",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2025-10-07",{"date":38,"type":20},"2030-03-30",{"name":40,"class":41},"Amgen","INDUSTRY",16,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100566895","a-study-to-learn-about-how-safe-darolutamide-is-and-how-well-it-works-in-combination-with-androgen-deprivation-therapy-and-docetaxel-in-routine-medical-care-for-japanese-men-with-low-volume-metastatic-hormone-sensitive-prostate-cancer-100566895","NCT06661122","A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer","An Observational Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Low-volume Metastatic Hormone-sensitive Prostate Cancer","HAYATE","Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of prostate.\n* Patients have low-volume of metastatic disease documented by either by a positive bone scan, or for soft tissue either by contrast-enhanced abdominal\u002Fpelvic\u002Fchest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigator. Low-volume metastasis criteria is defined as \"not\" meeting the high-volume criteria of the CHAARTED trial; high-volume meet the presence of visceral metastases, or four or more bone lesions including at least one outside the vertebral column or pelvis.\n* Documented diagnosis of mHSPC.\n* Patients on triplet regimen previously decided by the investigator irrespective of enrollment in the study.\n* Start ADT within 6 months before or at the index date.\n* Signed informed consent: If an eligible patient is deceased at the time of study initiation, informed consent from the legally representative(s) of the patient is required. Opt-out consent is acceptable in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects only when it is difficult to obtain signed informed consent from the patient or their legal representative.\n\nExclusion Criteria:\n\n* Patients treated with docetaxel before darolutamide start.\n* Participation in an investigational program with interventions outside of routine clinical practice.\n* Contra-indications to darolutamide, docetaxel and ADT according to the local marketing authorization.\n* Participation in the PASS of darolutamide in patients with mHSPC (DADOX \\[NCT06010914\\]).",{"count":52,"type":20},100,"OBSERVATIONAL","This is an observational study in which medical records of Japanese men with low-volume metastatic hormone-sensitive prostate cancer (mHSPC), who received treatment with a combination therapy of darolutamide with an androgen deprivation therapy (ADT) and docetaxel, will be collected and studied.\n\nThe study drug darolutamide, in combination with ADT and docetaxel is an approved treatment for another type of prostate cancer. To better understand the impact of this combination therapy on low-volume mHSPC and make better treatment choices, more knowledge is needed. ADT is a hormone therapy that lowers the level of testosterone, a male hormone, and slows down the growth of cancer cells. Darolutamide blocks androgen signals to slow the growth of the cancer cells. Docetaxel is a type of chemotherapy used to treat different types of cancer. It works by stopping the growth and spread of cancer cells.\n\nThe prostate gland is a male reproductive gland found below the bladder. Low-volume mHSPC is a cancer of the prostate gland that has spread beyond the gland to three or fewer bones but has not reached organs like the lungs and liver. The prostate cancer is considered hormone sensitive when it responds to an anti hormonal therapy.\n\nIn this study, only observations from routine clinical practices will be made. Participants will receive darolutamide, in combination with ADT and docetaxel as prescribed by their doctors during routine medical care. The participants will not receive any advice on treatment or any changes to healthcare as a part of the study.\n\nThe main purpose of this study is to learn more about how safe darolutamide is and how well it works in combination with ADT and docetaxel in adult Japanese men with mHSPC in routine medical care.\n\nTo do this, researchers will assess the following information about participants after one year of receiving the combination therapy by their doctors:\n\n• the number of participants who achieve normal levels of prostate specific antigen (PSA).\n\nPSA is a protein found in the blood that helps doctors monitor prostate cancer.\n\n• the number of participants who have adverse events (AEs), serious adverse events (SAEs), and adverse events of special Interest (AESIs) that lead to discontinuation or change in the dose of darolutamide or docetaxel during the study.\n\nAEs are medical problems that the participants had during the study that may or may not be related to the study treatment.\n\nSAEs are AEs that lead to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby to be born with medical problems, or is medically important.\n\nAESIs are specific medical problems the participants had during the study that may be related to heart, lung, liver etc.\n\nThe data will come from the participant's medical records and will be collected between October 2024 and June 2031. Researchers will only look at the health records from adult men with mHSPC in Japan. No separate visits are required as part of the study. The participants will only visit their doctor at the study clinic as part of their routine medical care.",[26,56],"Low-volume Metastasis",[58],"mHSPC","2026-06-23",{"date":61,"type":34},"2026-06-24",{"date":63,"type":34},"2024-11-18",{"date":65,"type":20},"2031-08-31",{"name":67,"class":41},"Bayer",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100607572","phase-1-tulmistar-02-a-phase-iii-open-label-study-of-tulmimetostat-in-combination-with-darolutamide-vs-darolutamide-and-tulmimetostat-with-abiraterone-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-mhspc-100607572","NCT07190300","TulmiSTAR-02: A Phase I\u002FII Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer","TulmiSTAR-02","Key Inclusion Criteria:\n\n* Adult men ≥ 18 years old with de novo or recurrent mHSPC (without neuroendocrine or small cell features). The tumor lesion(s) may be located in the bone, soft tissue\u002Fvisceral region, or both.\n* Participants must have castrate levels of testosterone, i.e., ≤ 50 ng\u002FdL (≤ 1.7 nM).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n* Adequate bone marrow and organ function\n* Prior ADT: Participants must have started ADT at least 1 month (at least 28 days) but no more than 12 months before study entry and be willing to continue ADT during treatment\n* Prior taxane use for mHSPC is permitted:\n\n  \\~ Phase I and II: Participants may have received, but not progressed on, one prior taxane-based therapy. Phase II: Limited to 25% participants with prior taxane use.\n* Prior ARPI is allowed in both Phase I and Phase II:\n\n  1. Prior ARPI use in biochemical recurrence (BCR) or curative treatment is allowed for any duration, provided therapy was discontinued and participant had no evidence of conventional imaging positive metastatic disease at that time\n  2. Prior ARPI use in mHSPC is permitted but not mandated. - If participants meet all study eligibility criteria, they are required to stop their prior ARPI after providing informed consent and remain off ARPI until Cycle 1 Day 1, when study treatment is initiated.\n\n     * Phase I: Allowed for any duration.\n     * Phase II: Allowed prior exposure to ARPI is ≤4 months.\n     * Phase II: Participants with ongoing use of darolutamide are not eligible. Participants with ongoing ARPI are eligible for a switch from their ongoing ARPI therapy if they have not progressed to CRPC disease, and meet any of the criteria, indicative of suboptimal biochemical response, or intolerability, as assessed by the Investigator.\n* Other permitted prior local therapy for mHSPC:\n\n  * Phase I and II: Prior prostate-directed radiation or surgical intervention. Radiation must be completed before study entry; surgery at least 2 weeks prior.\n\nKey Exclusion Criteria:\n\n* Participants with evidence of mCRPC or biochemical recurrence \u002F PSA only disease or asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy and with normal PSA for ≥ 1 year prior to the start of study treatment.\n* Participants who have not received ARPI treatment for mHSPC and present with PSA levels of ≤0.5 ng\u002FmL or those with prior\u002Fongoing ARPI treatment presenting with PSA levels of ≤ 0.2 ng\u002FmL prior to treatment assignment\u002Frandomization.\n* Participants with CNS metastases are excluded unless:\n\n  * they have received prior therapy (e.g. surgery, radiotherapy, gamma knife), are neurologically stable and asymptomatic.\n  * they are not receiving corticosteroid for the purpose of maintaining neurologic integrity and have baseline and subsequent radiological imaging of the brain.\n* Concurrent use of first-generation anti-androgens (like bicalutamide). Prior use of a first-generation anti-androgen drug in the context of ADT initiation with a GNRH analog is allowed, provided it was administered for ≤14 days and the last dose was administered ≥7 days from the study entry.\n* Systemic ketoconazole is used as antineoplastic treatment for prostate cancer.\n* Previous exposure to radioligand therapy.\n* Treatment with any investigational agent within 28 days (or 5 half-lives, whichever is longer) prior to study entry.\n* Previous treatment with any Polycomb Repressive Complex 2 (PRC2) inhibitor, including but not limited to Enhancer of Zeste Homolog 2 (EZH2) inhibitors, EZH2\u002F1 inhibitors, or embryonic ectoderm development (EED) inhibitors.\n* Herbal products that may decrease PSA levels within 4 weeks prior to the start of study drug treatment and while on study.\n* Participants taking prohibited medication(s) (e.g., strong CYP3A4 inducers or strong or moderate CYP3A4 inhibitors that cannot be stopped within 7 days or 5 half-lives (whichever is longer) prior to study treatment and for the duration of the study treatment or prohibited herbal product(s) that cannot be stopped 7 days prior to study treatment.\n\nOther inclusion\u002Fexclusion criteria may apply",{"count":78,"type":20},181,[23,80],"PHASE2","The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).",[83],"Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)",[83,85,86,87,88,89,75],"Enhancer of Zeste Homolog 2 (EZH2)","Androgen Receptor (AR)","Androgen Receptor Pathway Inhibitors (ARPIs)","Prostate-Specific Antigen (PSA)","Biochemical Response Rate (BCR)","2026-06-19",{"date":59,"type":34},{"date":93,"type":34},"2026-01-13",{"date":95,"type":20},"2032-08-02",{"name":97,"class":41},"Novartis Pharmaceuticals",31,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":68},"100609566","phase-2-optimal-psa-triggered-individual-management-of-androgen-sensitive-prostate-cancer-100609566","NCT07216248","Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer","A Phase II Randomized, Decentralized, De-escalation Study in Patients With Metastatic Hormone-Sensitive Prostate Cancer Achieving Optimal PSA Response (OPTIMAS)","OPTIMAS","Inclusion Criteria:\n\nCohort A Eligibility (Step 1 Registration)\n\n* Participant aged ≥ 18 years\n* Hormone-sensitive prostate cancer with histologically\u002Fcytologically confirmed adenocarcinoma without small cell histology.\n* Metastasis detected any time prior to study registration on conventional or functional imaging as determined by the treating investigator and can be of any site.\n* Baseline testosterone \\>50 ng\u002Fdl before start of therapy for metastatic disease\n* PSA ≥ 1 ng\u002FmL before start of therapy for metastatic disease\n* ECOG Performance Status ≤ 2\n* Eligible to receive standard of care treatment with relugolix and APRI per clinical investigator.\n* Participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception requirements as described in Section 5.5.1.\n\n  * If the risk of seminal transfer from the participant is present, the participant must agree to use a condom during sexual intercourse as described in Section 5.5.2.\n  * Participants must agree not to donate sperm from the start of study therapy until 3 months after the last dose of study therapy.\n* Clinically significant adverse effects from any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy) must have resolved or have been determined to be clinically stable per the Investigator.\n* Has access to a smartphone and wireless services and is able to download and navigate study specific applications.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nCohort A Eligibility (Step 2 Registration) -PSA ≤ 0.2 ng\u002FmL after 6-12 months of relugolix and androgen receptor pathway inhibitor treatment. Androgen receptor pathway inhibitor includes abiraterone, enzalutamide, apalutamide, darolutamide or similar drugs.\n\nCohort B Eligibility\n\n* Participant aged ≥ 18 years\n* Hormone-sensitive prostate cancer with histologically\u002Fcytologically confirmed adenocarcinoma without small cell histology.\n* Metastasis detected any time prior to study registration on conventional or functional imaging as determined by clinical investigator and can be of any site.\n* PSA ≤ 0.2 ng\u002FmL after treatment with androgen deprivation therapy or androgen receptor pathway inhibitor treatment or both of any duration. Androgen deprivation therapy in this context includes gonadotropin-releasing hormone agonists and antagonists. Androgen receptor pathway inhibitors include abiraterone, enzalutamide, apalutamide, darolutamide or similar drugs.\n* Eligible to receive standard of care treatment with relugolix and APRI per clinical investigator.\n* Participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception requirements as described in Section 5.5.1.\n\n  * If the risk of seminal transfer from the participant is present, the participant must agree to use a condom during sexual intercourse as described in Section 5.5.2.\n  * Participants must agree not to donate sperm from the start of study therapy until 3 months after the last dose of study therapy.\n* Has access to a smartphone and wireless services and is able to download and navigate study specific applications.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\nCohort A Eligibility (Step 1 Registration)\n\n* Participant received androgen deprivation therapy (defined as leuprolide or surgical castration) for metastatic hormone-sensitive prostate cancer.\n* The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.\n* Known brain metastases or cranial epidural disease.\n\n  --Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and\u002For surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically stable and receiving a stable or decreasing corticosteroid dose at the time of study entry.\n* Current evidence of uncontrolled, significant intercurrent illness, infection, non-compliance or other safety concerns which may affect clinical trial participation.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3).\n* Participants taking prohibited medications as described in Section 6.6.2.\n\nCohort A Eligibility (Step 2 Registration)\n\n* Receiving other systemic anti-cancer therapy for prostate cancer. Prior treatment before Step 2 registration is allowed.\n* Progression to metastatic castration-resistant prostate cancer per clinical investigator.\n* The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.\n* Participants taking prohibited medications as described in Section 6.6.2.\n\nCohort B Eligibility\n\n* Receiving other systemic anti-cancer therapy for prostate cancer.\n* History of surgical castration.\n* The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.\n* Known brain metastases or cranial epidural disease.\n\n  --Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and\u002For surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically stable and receiving a stable or decreasing corticosteroid dose at the time of study entry\n* Current evidence of uncontrolled, significant intercurrent illness, infection, compliance or other safety concerns which may affect clinical trial participation.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3).\n* Participants taking prohibited medications as described in Section 6.6.1.",{"count":108,"type":20},160,[80],"The purpose of this study is to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.",[26],"2026-06-18",{"date":59,"type":34},{"date":115,"type":34},"2025-10-27",{"date":117,"type":20},"2031-10",{"name":119,"class":120},"University of Utah","OTHER",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":68},"100642076","phase-2-risk-adapt-protocol-in-metastatic-hormone-sensitive-prostate-cancer-mhspc-100642076","NCT07645326","RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)","A Pragmatic Phase 2 Trial of Risk-Adapted Treatment Approaches Including Treatment De-escalation to Minimize Adverse Effects of Hormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer.","RISK-ADAPT","Inclusion Criteria:\n\n1. Adult patients with metastatic castrate sensitive prostate cancer that are eligible for standard of care (SOC) per treating physician.\n\n   a. Low risk SOC: ADT + ARPI + radiation to the prostate i. For patients with low-risk disease (defined in Section 8.1), prior treatment with ADT or ARPI for up to 8 weeks for mCSPC is permitted; however, prior treatment with docetaxel is not allowed.\n\n   b. High risk SOC: ADT + ARPI +\u002F- docetaxel i. For patients with high-risk disease (defined in Section 8.1), prior treatment with ADT, ARPI, or docetaxel for up to 8 weeks for mCSPC is permitted.\n2. Patients who can give informed consent and are willing to comply with follow-up visits and treatment plans.\n\nExclusion Criteria:\n\n1. Patients for whom, in the opinion of the investigator, participation in the study, use of the drugs outlined in the study, or use of the risk-adapted treatment de-escalation strategy is not appropriate or safe.\n2. Patients who have received prior treatment with any of the following:\n\n   1. Chemotherapy other than docetaxel for prostate cancer any time prior to enrollment;\n   2. Radiopharmaceuticals for prostate cancer any time prior to enrollment.\n3. Patients who have received treatment with radiotherapy (EBRT, brachytherapy, or radiopharmaceuticals) within 2 weeks before prior to the start of study treatment.\n4. Patients with prior treatment with an ARPI for non-metastatic disease within 6 months of diagnosis of metastatic disease are not eligible.\n\n   a. Note: Patients who were diagnosed with metastatic disease or more than 6 months after treatment with an ARPI non-metastatic disease are eligible.\n5. Patients who had previous (within 28 days before the start of study drug or 4 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).\n6. Patients with an inability to swallow oral medications in the opinion of the clinical investigator.\n7. Patients with leptomeningeal disease.",{"count":130,"type":20},108,[80],"This is a prospective, interventional, non-randomized, phase 2 study to assess oncologic outcomes of metastatic hormone-sensitive prostate cancer (mCSPC) patients who receive a risk-adapted treatment approach followed by treatment de-escalation at the Medstar Health network. A pragmatic design will be implemented in order to make the study available to patients at greatest needs from minority populations in the community. Additional assessments include quality-of-life (QoL) and sexual function changes as well as correlative studies. A maximum of 108 patients will be enrolled in this study. The investigators hypothesize that with a risk-adapted treatment approach followed by treatment de-escalation, more than 50% of patients will have radiographic progression-free survival (rPFS) at 36 months. Additionally, the investigators hypothesize that the risk-stratified de-escalation approach will result in fewer treatment-related adverse events and better QoL, compared to historical controls.",[26],"NOT_YET_RECRUITING","2026-06-15",{"date":137,"type":34},"2026-06-17",{"date":139,"type":20},"2026-08",{"date":141,"type":20},"2032-08",{"name":143,"class":120},"Georgetown University",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":170,"leadSponsor":172,"locationsCount":68},"100641941","phase-2-study-of-psma-targeted-therapy-and-androgen-receptor-suppression-in-low-volume-metastatic-prostate-cancer-sparkle-trial-100641941","NCT07650240","Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial","A Phase II Randomized Trial of Intermittent Androgen Deprivation Therapy Alone or Combined With [177Lu]Lu-PSMA-617, With or Without Abiraterone and Prednisone, in Patients With Low-Volume Metastatic Hormone-Sensitive Prostate Cancer","SPARKLE","Inclusion Criteria:\n\n* Male patients aged 18 years or older\n* Signed informed consent must be obtained prior to participation in the study\n* Histologically confirmed adenocarcinoma of the prostate\n* Prior treatment with radical prostatectomy or radiation therapy for localized disease is required\n* Prior treatment with ADT or androgen receptor pathway inhibitor (ARPI) or cytotoxic chemotherapy is permitted if:\n\n  * The last treatment \\> 12 months from enrollment on the trial\n  * The duration of treatment is less than 3 months and no evidence of disease progression on treatment\n* Disease detected on PSMA PET\u002FCT scan \\[PSMA-avid low volume metastasis (LVM)\\]. Patients with standardized uptake value maximum (SUVMax) lesion\u002Fliver \\>1 \\[molecular imaging PSMA (miPSMA) score of 2\\] or lesion\u002Fparotid \\> 1 (miPSMA score of 3) would be included. PET scanners used in the study will comply with current guidelines established by the European Association of Nuclear Medicine (EANM) Research Limited (Ltd) (EARL) for harmonizing PET\u002FCT image acquisition and reconstruction\n* Patients with hormone sensitive low volume metastatic disease (LVM); either de novo metastatic or recurrent disease. LVM, as assessed on PSMA PET\u002FCT is defined as:\n\n  * =\\\u003C 10 total metastatic spots\n\n    * Lymph nodes with short axis of =\\\u003C 2.5 cm\n    * Total tumor volume (TTV) \\\u003C 200 mL\n  * =\\\u003C 4 bone metastases\n  * No brain or liver metastases\n* Eastern Cooperative Oncology Group (ECOG) performance 0 - 2\n* Hemoglobin \\>= 9 g\u002FdL\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Absolute neutrophil count \\>= 1,500\u002Fmm\\^3\n* Serum bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) =\\\u003C 2.5 x ULN\n* Serum creatinine =\\\u003C 1.5 x ULN or an estimated glomerular filtration rate (eGFR) \\>= 50 mL\u002Fmin\u002F1.73m\\^2\n* Able to start therapy within 28 days of screening\n* Expected life expectancy \\> 6 months\n\nExclusion Criteria:\n\n* PSMA-undetectable disease defined as rising prostate specific antigen (PSA) with absence of PSMA-positive lesions in PSMA PET\u002FCT imaging\n* PSMA-negative disease defined as lesions detected on imaging that are deemed concerning for active cancer metastasis with PSMA SUVmax less than liver and meeting specific size criteria: lymph nodes with short axis of \\>= 2.5 cm, visceral lesions with a solid appearance (soft tissue density) \\>= 1 cm, and bone metastases with a measurable soft tissue component \\>= 1 cm\n* Patient with in-field failure (disease recurrence in prostate bed after primary definitive prostatectomy or radiotherapy)\n* Patient with spinal metastatic disease-causing cord compression\n* Patient with prior disease progression on ADT \\[castration resistance prostate cancer (CRPC)\\]\n* Prior treatment with ADT or cytotoxic chemotherapy or ARPI within less than 12 months from enrollment on the trial\n* Prior treatment with ADT or ARPI or cytotoxic chemotherapy is permitted only if more than 3 months treatment duration and no evidence of disease progression on treatment\n* Patients with severe \\[Common Terminology Criteria for Adverse Events (CTCAE) grade \\> 2\\] xerostomia\n* Patients with well documented history of myelosuppression or renal disease that might impair their participation in the trial per medical advice\n* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible\n* Estimated life expectancy \\\u003C 6 months\n* Concurrent serious medical co-morbidities as determined by study investigator and expected to impair participation in the study\n\n  * Subjects with female partners of reproductive potential are required to use effective, medically acceptable methods of birth control (e.g., spermicide in conjunction with a barrier such as a condom or sexual abstinence) while on this study, and for 14 weeks after the last dose of 177Lu-PSMA-617",{"count":153,"type":20},202,[80],"This phase II trial tests leuprolide acetate alone versus in combination with 177Lu-PSMA-617, with or without abiraterone acetate and prednisone, for the treatment of hormone-sensitive prostate cancer has spread to a limited number of anatomic sites at the time of initial diagnosis (de novo low volume metastasis) or that has come back after a period of improvement (recurrent). Standard of care treatment for prostate cancer usually includes androgen deprivation therapy, with or without abiraterone acetate and prednisone. Leuprolide acetate is a form of androgen deprivation therapy. It blocks the body from making testosterone (a male hormone) and estradiol (a female hormone). It may stop the growth of prostate cancer cells that need testosterone to grow. 177Lu-PSMA-617 is a type of radioconjugate drug. Upon administration, vipivotide tetraxetan targets and binds to prostate specific membrane antigen (PSMA)-expressing tumor cells. Upon binding, PSMA-expressing tumor cells are destroyed by 177Lu through the specific delivery of radiation. PSMA, a tumor-associated antigen and type II transmembrane protein, is overexpressed on prostate tumor cells. Abiraterone acetate is a type of anti-androgen drug. It blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of cancer cells that need androgens to grow. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving 177Lu-PSMA-617 in combination with leuprolide acetate, with or without abiraterone acetate and prednisone, may be more effective at treating patients with recurrent or de novo low volume metastatic hormone-sensitive prostate cancer than giving leuprolide acetate alone.",[157,158,159,26,160,161,162,163,164,165,166,167],"Recurrent Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8","Castration-Sensitive Prostate Cancer","Prostate Cancer","Prostate Adenocarcinoma","Adenocarcinoma of the Prostate","Localized Prostate Carcinoma","Metastatic Prostate Cancer","Metastatic Prostate Adenocarcinoma","Advanced Prostate Cancer","Advanced Prostate Adenocarcinoma",{"date":137,"type":34},{"date":31,"type":20},{"date":171,"type":20},"2030-12-30",{"name":173,"class":120},"Mayo Clinic",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":68},"100642088","phase-2-psma-petct-guided-sbrt-plus-darolutamide-in-mhspc-100642088","NCT07649421","PSMA PET\u002FCT-Guided SBRT Plus Darolutamide in mHSPC","A Multicenter, Prospective, Randomized Controlled Phase II Trial of PSMA PET\u002FCT-Guided Stereotactic Body Radiotherapy Combined With Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer","PSMA-DaroRT","Inclusion Criteria:\n\n* Male participants aged ≥18 years and \\\u003C85 years.\n* Histologically confirmed prostate adenocarcinoma.\n* No neuroendocrine carcinoma, ductal adenocarcinoma, small-cell carcinoma, signet-ring cell carcinoma, or sarcomatoid carcinoma component.\n* Metastatic prostate cancer confirmed by imaging or pathological evidence.\n* PSMA PET\u002FCT and FDG PET\u002FCT show ≤20 metastatic lesions.\n* PSMA PET\u002FCT and FDG PET\u002FCT show concordant tracer uptake activity.\n* No prior systemic or local anti-tumor treatment for prostate cancer.\n* No prior androgen deprivation therapy.\n* No prior first-generation antiandrogen therapy.\n* No prior androgen receptor signaling inhibitor therapy, including abiraterone, enzalutamide, apalutamide, rezvilutamide, or darolutamide.\n* No prior chemotherapy for prostate cancer.\n* No prior radical prostatectomy.\n* No prior radiotherapy for prostate cancer.\n* Expected survival \\>12 months.\n* Able to understand the study and voluntarily sign written informed consent.\n* Able and willing to comply with study visits and protocol procedures.\n* Willing to provide tumor tissue, blood, and other biological samples as required by the study protocol.\n* Absolute neutrophil count ≥1.5 × 10\\^9\u002FL.\n* Platelet count ≥100 × 10\\^9\u002FL.\n* Hemoglobin ≥90 g\u002FL.\n* Total bilirubin ≤1.5 × upper limit of normal.\n* Alanine aminotransferase and aspartate aminotransferase ≤2.5 × upper limit of normal.\n* Serum albumin ≥20 g\u002FL.\n* Serum creatinine ≤1.5 × upper limit of normal or creatinine clearance ≥50 mL\u002Fmin.\n* Eastern Cooperative Oncology Group performance status ≤2.\n\nExclusion Criteria:\n\n* Current or prior history of another primary malignancy.\n* History of another malignancy within 3 years that differs from the study cancer in primary site or histology.\n* History of papillary thyroid carcinoma is allowed if it is well controlled.\n* History of basal cell carcinoma of the skin is allowed if it is well controlled.\n* History of squamous cell carcinoma of the skin is allowed if it is well controlled.\n* History of cervical carcinoma in situ is allowed if it is well controlled.\n* Prior radical prostatectomy.\n* Prior external beam radiotherapy.\n* Prior radical or ablative local therapy for prostate cancer.\n* Prior treatment with an androgen receptor signaling inhibitor, including abiraterone, enzalutamide, apalutamide, rezvilutamide, or darolutamide.\n* Prior chemotherapy for prostate cancer.\n* Major surgery within 4 weeks before enrollment.\n* Serious trauma within 4 weeks before enrollment.\n* Contraindication to radiotherapy.\n* Spinal cord compression.\n* Active enteritis.\n* Severe pelvic infection.\n* Inability to maintain the required body position for radiotherapy.\n* History of allergy to PET\u002FCT tracer.\n* Nuclear medicine assessment showing super bone imaging.\n* Marked discordance between PSMA PET\u002FCT and FDG PET\u002FCT findings.\n* Disease progression during the 6-month run-in period of androgen deprivation therapy plus darolutamide before randomization.\n* Unacceptable toxicity during the 6-month run-in period of androgen deprivation therapy plus darolutamide before randomization.\n* No active tumor lesion on PSMA PET\u002FCT after the 6-month run-in period.\n* Allergy to any component of the study treatment.\n* Active or poorly controlled serious infection.\n* Human immunodeficiency virus infection.\n* Acute or chronic active hepatitis B infection, defined as positive hepatitis B surface antigen with hepatitis B virus DNA \\>1 × 10\\^3\u002FmL.\n* Acute or chronic active hepatitis C infection, defined as positive hepatitis C virus antibody with hepatitis C virus RNA \\>15 IU\u002FmL.\n* Active pulmonary tuberculosis.\n* Other serious infectious disease.\n* New York Heart Association class III or IV congestive heart failure.\n* Persistent symptomatic arrhythmia.\n* Uncontrolled atrial fibrillation.\n* Left ventricular ejection fraction below the lower limit of normal on repeated echocardiographic assessments.\n* Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.\n* Arterial thrombotic, embolic, or ischemic event within 6 months before enrollment.\n* Myocardial infarction within 6 months before enrollment.\n* Unstable angina within 6 months before enrollment.\n* Cerebrovascular accident within 6 months before enrollment.\n* Transient ischemic attack within 6 months before enrollment.\n* Medical condition requiring warfarin or coumarin anticoagulation therapy.\n* Uncontrolled hypercalcemia, defined as ionized calcium \\>1.5 mmol\u002FL, total calcium \\>12 mg\u002FdL, or corrected serum calcium above the upper limit of normal.\n* Symptomatic hypercalcemia requiring continuous bisphosphonate therapy.\n* Uncontrolled adrenal insufficiency.\n* History of abdominal fistula within 6 months before enrollment.\n* History of gastrointestinal perforation within 6 months before enrollment.\n* History of intra-abdominal abscess within 6 months before enrollment.\n* Severe non-healing wound.\n* Severe non-healing ulcer.\n* Gastrointestinal disease that may impair absorption.\n* Active peptic ulcer disease.\n* Uncontrolled nausea.\n* Uncontrolled vomiting.\n* Uncontrolled diarrhea.\n* History of small bowel resection that may impair drug absorption.\n* Other acute or chronic disease, psychiatric disorder, or laboratory abnormality that may increase the risk associated with study participation or study treatment.\n* Other acute or chronic disease, psychiatric disorder, or laboratory abnormality that may interfere with interpretation of study results.\n* Any other medical or psychological condition that, in the investigator's judgment, may affect participant safety, compliance, or study integrity.\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for this study.","85 Years",{"count":184,"type":20},254,[80],"This is a multicenter, randomized, open-label phase 2 study for men with metastatic hormone-sensitive prostate cancer. About 254 participants will first receive 6 months of darolutamide plus androgen deprivation therapy. Participants whose cancer has not progressed and who still have active tumor lesions on prostate-specific membrane antigen positron emission tomography\u002Fcomputed tomography (PSMA PET\u002FCT) will then be randomly assigned to one of two groups. One group will continue darolutamide plus androgen deprivation therapy. The other group will receive stereotactic body radiotherapy (SBRT) to all active tumor lesions identified by PSMA PET\u002FCT, while continuing darolutamide plus androgen deprivation therapy. The main purpose of this study is to find out whether adding PSMA PET\u002FCT-guided SBRT can help participants live longer without tumor growth seen on scans or death. The study will also evaluate prostate-specific antigen (PSA) changes, time to castration-resistant prostate cancer, overall survival, side effects, and quality of life.",[83],[189,190,191,192,193],"PSMA PET\u002FCT","SBRT","Darolutamide","Androgen Deprivation Therapy","Metastasis-Directed Therapy","2026-06-14",{"date":196,"type":34},"2026-06-16",{"date":198,"type":20},"2026-08-01",{"date":200,"type":20},"2031-10-01",{"name":202,"class":120},"West China Hospital",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":68},"100623374","how-darolutamide-plus-hormone-therapy-works-for-men-with-advanced-prostate-cancer-in-everyday-medical-practice-in-germany-100623374","NCT07395804","How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany","DAROlutamide DoUBlet Therapy in Daily Practice (DARO-DUB) - Real-world Evaluation of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Treated With Darolutamide Plus ADT in Germany","23146","Inclusion Criteria:\n\n* Male patients aged ≥ 18 years\n* Diagnosis of mHSPC with histological or cytological evidence for adenocarcinoma of prostate\n* Metastatic disease by conventional or new generation imaging\n\n  * Physician decision to initiate treatment with Darolutamide+ADT was made as per investigator's routine treatment practice prior to enrollment in the study\n  * Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).\n\nExclusion Criteria:\n\n* Darolutamide treatment started more than 30 days prior to study enrollment\n* ADT treatment started more than 12 weeks before the start of treatment with darolutamide plus ADT\n* Hypersensitivity to darolutamide or any other excipient\n* Other prior systemic hormonal or anti-cancer treatment for mHSPC\n* Participation in an investigational program for prostate cancer with interventions outside of routine clinical practice",{"count":212,"type":20},500,"Prostate cancer is a disease where cells in the prostate gland grow out of control. When prostate cancer has spread to other parts of the body but still responds to hormone treatment, it is called metastatic hormone-sensitive prostate cancer (mHSPC).\n\nThe usual treatment for this stage of prostate cancer is hormone therapy (called androgen-deprivation therapy or ADT) combined with another medicine that blocks the effect of male hormones on cancer cells, known as an androgen-receptor pathway inhibitor. Darolutamide is a newer type of androgen-receptor inhibitor.\n\nThe main goal of this study is to find out how well a combination of two treatments-darolutamide and hormone therapy (also called androgen-deprivation therapy or ADT)-works for men in Germany who have advanced prostate cancer that has spread to other parts of the body and still responds to hormone treatment. The study will look at how many men have very low or undetectable levels of a protein called prostate-specific antigen (PSA) in their blood after 12 months of treatment. PSA is a marker that doctors use to check how active prostate cancer is.\n\nThe study will also look at how long men live after starting this treatment, and will collect information about their health, the type of prostate cancer they have, and any other medicines they are taking. The study will last for 5 years. At the start of the study, the study doctor will collect information about each patient's background, such as age, other health problems, and details about their prostate cancer. This information will be taken from the patient's medical records if available. If some information is missing, the doctor may ask the patient directly.\n\nOther information will be collected as the study goes on. This includes details about the patient's treatment, how they are doing during their regular medical visits, and any changes in their health. These check-ups and data collection will happen as part of the patient's usual care, including at the beginning of treatment, during treatment visits, follow-up visits, and at the end of the study observation period.",[26],"2026-05-27",{"date":217,"type":34},"2026-05-29",{"date":219,"type":34},"2026-04-14",{"date":221,"type":20},"2031-02-15",{"name":67,"class":41},{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":68},"100611502","phase-3-a-phase-iii-clinical-study-of-rezvilutamide-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-100611502","NCT07241416","A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer","A Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Study of Rezvilutamide Combined With Androgen Deprivation Therapy (ADT) Versus Enzalutamide Combined With ADT for Treating Low-volume Metastatic Hormone Sensitive Prostate Cancer (mHSPC)","Inclusion Criteria:\n\n1. Voluntarily participates in this clinical trial, with an understanding of the study procedures and signed informed consent;\n2. Age ≥ 18 years;\n3. Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine differentiation or small cell features;\n4. Metastatic hormone sensitive prostate cancer;\n5. ECOG PS: 0-1;\n6. Planned to receive and maintain ADT during the study period;\n7. Adequate hepatic, renal, heart, and hematological functions;\n8. Determined by the investigator to be able to comply with the study protocol;\n9. Fertile subjects must use effective contraception or abstain from sexual activity and sperm donation until 3 months after last exposure to rezvilutamide or enzalutamide. Subjects must use condoms plus an additional effective contraceptive method during sexual activity with a fertile female partner throughout treatment and for 3 months post-treatment.\n\nExclusion Criteria:\n\n1. Prior treatment with ADT, chemotherapy, surgery, external-beam radiotherapy, brachytherapy, radiopharmaceuticals, or investigational local therapy for metastatic prostate cancer, except as specifically allowed by the protocol;\n2. Previous use of second-generation androgen receptor antagonists, ketoconazole, abiraterone acetate, or other investigational drugs inhibiting androgen synthesis for prostate cancer treatment; or plans to use any second-generation androgen receptor antagonist other than the study drug during the study treatment period;\n3. Total PSA has decreased to undetectable levels at baseline;\n4. Have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks before randomization: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease PSA levels;\n5. Planned to initiate any other anti-tumor therapies during the study;\n6. Known history of hypersensitivity to rezvilutamide, enzalutamide, or any of their components;\n7. Unable to swallow, chronic diarrhea or intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;\n8. History of seizure or certain conditions that may predispose to seizure;\n9. Presence of clinically significant cardiovascular diseases within 6 months prior to randomization;\n10. Any other malignancy within 5 years prior to randomization (except as specifically allowed by the protocol);\n11. Active HBV or HCV infection;\n12. History of immunodeficiency (including HIV-positive status, other acquired or congenital immunodeficiency disorders) or organ transplantation;\n13. Any concomitant condition that, in the opinion of the investigator, would seriously jeopardize patient safety, confound study findings, or compromise the patient's ability to complete the study (e.g., hypertension inadequately controlled despite medication, severe diabetes, neurologic or psychiatric disorders, etc.) or any other circumstance.",{"count":231,"type":20},206,[233],"PHASE3","This study aims to compare the efficacy and safety of rezvilutamide with enzalutamide in the treatment of patients with low-volume metastatic hormone sensitive prostate cancer.",[26],"2026-05-07",{"date":238,"type":34},"2026-05-11",{"date":240,"type":34},"2025-12-05",{"date":242,"type":20},"2028-09",{"name":244,"class":41},"Jiangsu HengRui Medicine Co., Ltd.",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":278},"100606866","quality-of-life-functional-and-cognitive-outcomes-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-100606866","NCT07181122","Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer","Prospective Observational Evaluation of Quality of Life, Functional Status, and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer Undergoing Androgen Receptor Pathway Inhibitor Therapy","PRO-MIND","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically or cytologically confirmed metastatic hormone-sensitive prostate cancer (mHSPC)\n* Planned initiation of androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (abiraterone, apalutamide, or enzalutamide) as part of routine clinical care\n* Ability to complete patient-reported outcome questionnaires (FACT-Cog, FACT-F, PHQ-9, PSQI)\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Prior systemic therapy for metastatic prostate cancer (except ≤3 months of ADT)\n* Known history of severe cognitive impairment that precludes completion of questionnaires\n* Concurrent active malignancy requiring systemic treatment\n* Inability to comply with study procedures or follow-up\n* Any condition judged by the investigator to compromise participation or data integrity",{"count":254,"type":20},102,"This prospective observational study will evaluate quality of life, functional status, and cognitive outcomes in men with metastatic hormone-sensitive prostate cancer (mHSPC) receiving androgen receptor pathway inhibitors (ARPIs) in addition to standard androgen deprivation therapy. ARPIs in this study include abiraterone acetate, apalutamide, enzalutamide, and darolutamide, depending on local availability. A total of 102 patients will be enrolled from two academic oncology centers in Türkiye.\n\nParticipants will be assessed at baseline, 3 months, and 6 months using validated Turkish versions of established questionnaires: Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Patient Health Questionnaire-9 (PHQ-9), and Pittsburgh Sleep Quality Index (PSQI). Clinical parameters, ECOG performance status, routine laboratory results, and treatment-related adverse events will also be recorded.\n\nThe primary outcomes are longitudinal changes in FACT-Cog and FACT-F scores. Secondary outcomes include changes in depression, sleep quality, laboratory results, and adverse events. This study will provide real-world evidence on how ARPI therapy affects cognitive health and quality of life in patients with mHSPC.",[83],[28,58,258,259,260,261,191,262,263,264,265,266,267],"Androgen receptor pathway inhibitors","Abiraterone","Apalutamide","Enzalutamide","Quality of life","Cognitive function","Fatigue","Depression","Sleep quality","Patient-reported outcomes","2026-04-26",{"date":270,"type":34},"2026-04-28",{"date":272,"type":34},"2025-10-22",{"date":274,"type":20},"2026-09-15",{"name":276,"class":277},"Ankara Etlik City Hospital","OTHER_GOV",2,{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":289,"conditions":290,"keywords":294,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":306},"100580278","procare---prostate-cancer-real-world-evidence-registry-100580278","NCT06835218","PROCARE - PROstate Cancer Real World Evidence Registry","PROstate CAncer Real World Evidence Registry: RECURRENT AND METASTATIC PROSTATE CANCER","PROCARE","Inclusion Criteria:\n\n* Adult prostate cancer patients (age ≥18 years).\n* Diagnosis at time of study inclusion Cohort 1: biochemical recurrence (BCR) after local curative intended treatment (e.g. radical prostatectomy, radiotherapy of the prostate or combination thereof) Cohort 2: non-metastatic castration-resistant prostate cancer (nmCRPC) or Cohort 3: metastatic hormone sensitive prostate cancer (mHSPC) or Cohort 4: metastatic castration-resistant prostate cancer (mCRPC) (irrespective of treatment choice, treatment line)\n* Patients who will receive a new line of systemic therapy at the time of study entry or up to 4 weeks thereafter. Regarding Cohort 4 this includes patients with a new diagnosis of mCRPC (=first line mCRPC) after either treatment for mHSPC or non-metastatic CRPC as well as patients with prior mCRPC treatments (2nd, 3rd, … line).\n* For Cohorts 1, 2 and 3: Disease proven by clinical measures (i.e. standard imaging) to be either unsuitable for local salvage treatment (e.g. surgery, radiotherapy) or local treatment is declined by the patient.\n* Patients, who are able and willing to sign the informed consent form\n\nExclusion Criteria:\n\n• Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician",{"count":288,"type":20},5000,"The aim of this registry study with long-term follow-up is to record the course of therapy and disease in patients with recurrent and metastatic prostate cancer. The following patient groups are planned:\n\n* Patients with a recurrence of PSA after surgical removal or radiation of the prostate due to prostate cancer; so-called PSA recurrence (relapse) or biochemical recurrence.\n* Patients with a PSA recurrence who have received treatment by hormone deprivation therapy (so-called androgen deprivation) and in whom the PSA value has nevertheless risen again without spreading to other organs or parts of the body, so-called non-metastatic castration-resistant prostate cancer.\n* Patients with proven spread to other organs or parts of the body (= metastases, e.g. in the bone) without hormone deprivation therapy having been initiated, so-called metastatic hormone-sensitive prostate cancer.\n* Patients with prostate cancer and spread to other organs or parts of the body (= metastases) in whom the tumor disease has progressed despite hormone withdrawal treatment (e.g. as evidenced by an increase in PSA), so-called metastatic castration-refractory prostate cancer.\n\nThese four groups of patients are enrolled and observed independently of each other at different time periods.",[160,291,292,26,293],"Biochemical Recurrence of Malignant Neoplasm of Prostate","Non-metastatic Castration-resistant Prostate Cancer","Metastatic Castration-resistant Prostate Cancer",[295],"prostate, cancer, metastatic, systemic therapy","2026-03-10",{"date":298,"type":34},"2026-03-12",{"date":300,"type":34},"2024-01-29",{"date":302,"type":20},"2032-12-31",{"name":304,"class":305},"UroTrials Company (GmbH)","NETWORK",53,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":315,"enrollmentInfo":316,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":68},"100613607","phase-2-convert-hb1-radical-prostatectomy-after-systemic-therapy-for-high-volume-metastatic-hormone-sensitive-prostate-cancer-100613607","NCT07268794","CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate Cancer","A Multicenter, Prospective, Randomized Controlled Phase II Clinical Trial of Prostatectomy After Conversion Therapy With Second-generation Antiandrogen Agents Plus ADT in Patients With High-volume mHSPC(CONVERT-HB1)","CONVERT-HB1","Inclusion Criteria:\n\n1. Male patients aged \\>18 and ≤70 years, or with an estimated life expectancy \\>10 years.\n2. Histologically or cytologically confirmed prostate adenocarcinoma with neuroendocrine differentiation ≤10%, and no small cell or signet-ring cell carcinoma component.\n3. High-volume metastatic disease according to CHAARTED definition: presence of visceral metastasis and\u002For ≥4 bone lesions with at least one lesion outside the axial skeleton (vertebral bodies and pelvis).\n4. Newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) who started intensified endocrine therapy within 3 months.\n5. ECOG performance status 0-2.\n6. Adequate bone marrow, liver, renal, and coagulation function as defined in the protocol (ANC ≥1.5×10\\^9\u002FL, hemoglobin ≥9.0 g\u002FdL, platelets ≥80×10\\^9\u002FL; TBIL ≤1.5×ULN; AST\u002FALT\u002FALP ≤2.5×ULN; albumin ≥30 g\u002FL; creatinine ≤2×ULN or creatinine clearance ≥30 mL\u002Fmin; INR ≤1.5 in patients not receiving anticoagulation).\n7. Patients voluntarily sign informed consent and are willing and able to comply with study procedures.\n\nExclusion Criteria:\n\n1. History of hypersensitivity or intolerance to any study drugs.\n2. mCRPC (metastatic castration-resistant prostate cancer).\n3. Oligometastatic mHSPC intended for upfront radical prostatectomy.\n4. History of seizure, medications that may lower seizure threshold, or conditions predisposing to seizures (e.g., TIA, stroke, significant head trauma with loss of consciousness requiring hospitalization) within 12 months before starting study treatment.\n5. Major surgery within 4 weeks prior to starting study treatment.\n6. Significant cardiovascular or cerebrovascular disease within 6 months (e.g., unstable angina, myocardial infarction, NYHA class III or higher heart failure, stroke, clinically significant arrhythmia requiring treatment).\n7. Conditions affecting drug intake or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction).\n8. Active infection (e.g., HIV positive, HBsAg positive, HCV positive) which in the investigator's opinion may affect safety or efficacy assessment.\n9. Other malignancies within the past 3 years, except adequately treated basal cell carcinoma of the skin.\n10. Known brain metastases or leptomeningeal disease.\n11. Concurrent participation in another interventional clinical trial or receiving other investigational drugs\u002Fdevices.\n12. Poor compliance or inability to adhere to study procedures and follow-up.\n13. Any other severe uncontrolled comorbidities (e.g., poorly controlled hypertension, severe diabetes, neurologic or psychiatric disorders) or conditions that may interfere with study conduct or interpretation, as judged by the investigator.","70 Years",{"count":317,"type":20},112,[80],"This is a prospective, randomized, open-label, phase II multicenter clinical trial evaluating the efficacy and safety of radical prostatectomy in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) who achieve good response after systemic therapy with androgen deprivation therapy (ADT) plus second-generation antiandrogens such as rezvilutamide. All eligible patients will receive 6 months of induction systemic therapy (ADT plus second-generation androgen receptor signaling inhibitors, with or without docetaxel or other systemic agents). Patients who achieve PSMA PET\u002FCT \"conversion success\" (no metabolically active lesions; all metastases with SUVmax below liver background or blood pool) will be randomized 1:1 to continue systemic therapy alone (control arm) or receive local prostate treatment (radical prostatectomy or radiotherapy) plus systemic therapy (experimental arm). The primary endpoint is radiographic progression-free survival (rPFS). Key secondary endpoints include overall survival (OS), biochemical progression-free survival (bPFS), PSA response rate, quality of life, conversion success rate, and safety.",[164,321,83],"Prostate Cancer (Adenocarcinoma)",[323,324,325,326,327,328,329],"High-volume mHSPC","Androgen deprivation therapy","Second-generation antiandrogens","Rezvilutamide","Radical prostatectomy","Radiotherapy","Conversion therapy",{"date":331,"type":34},"2025-12-08",{"date":333,"type":20},"2025-11-30",{"date":335,"type":20},"2027-12-30",{"name":337,"class":120},"Fudan University",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":21,"phases":348,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":361},"100489194","multimodal-approach-in-patients-with-mhspc-randomized-trial-of-apaadt-vs-apa-adt-and-local-treatment-100489194","NCT05649943","Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment","APPROACH : Multimodal Approach in Patients With mHSPC. A Pragmatic Randomized Trial of Apalutamide Plus Androgen Deprivation Therapy (APA-ADT) Versus APA-ADT Plus Local Treatment. A Meet-URO 29 Study","APPROACH","Inclusion Criteria:\n\n* Age \\> 18\n* Histologically confirmed diagnosis of prostate adenocarcinoma\n* Metastatic disease documented by ≥1 bone lesion with Technetium 99m (99mTc) bone scan. Individuals with only one bone lesion should have confirmation of that lesion on CT or MRI.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) Grade ≤ 2\n* No previous treatment with antiandrogens or GnRH analogues, or a treatment ≤ 3 months.\n* No previous systemic or local treatment for prostate adenocarcinoma, including pelvic radiotherapy.\n* Laboratory values at the time of screening:\n\n  a. Neutrophils ≥ 1500\u002FμL b. Hemoglobin ≥ 9.0 mg\u002FμL (no transfusions in the past 28 days) c. Platelets ≥ 100,000\u002FμL d. Creatinine ≤ 2 x upper limit of normal and serum albumin ≥ 3.0 g\u002FdL f. Total bilirubin ≤ 1.5 x upper limit of normal \\[NOTE: In subjects with Gilbert syndrome, if total bilirubin is \\>1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is ≤ 1.5 x ULN subjects may be eligible\\]; g. AST and ALT ≤ 2.5 x upper limit of normal\n* Able to swallow Apalutamide tablets whole.\n* All subjects must sign an Informed Consent Form indicating that they understand the purpose of the study and its procedures and intend to participate. The subject must be willing and must be able to comply with the restrictions specified in this protocol.\n\nInclusion criteria for cytoreductive surgery:\n\n* Age \\>18 years\n* Clinical stage cT3\n* Robot-assisted radical prostatectomy with iliac obturator lymphadenectomy\n* Surgical piece management criteria similar to Proteus criteria.\n\nExclusion Criteria:\n\n* Pathologic findings consistent with small cell, ductal, or neuroendocrine prostate cancer.\n* Known brain metastases.\n* Lymph node metastases only.\n* Visceral metastases.\n* Patients not eligible for surgery or radiotherapy.\n* Unacceptable increase in cardiovascular risk, defined as the occurrence of at least one of the following episodes in the 6 months prior to randomization: unstable angina, myocardial infarction, symptomatic congestive heart failure, clinically significant thromboembolic events (e.g., pulmonary embolism), or clinically significant ventricular arrhythmias .\n* Uncontrolled high blood pressure (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg).\n* Previous treatment with antiandrogens, GnRH analogues, or other systemic treatments for adenocarcinoma of the prostate.\n* Previous local treatment with surgery and\u002For radiotherapy.\n* Any prior malignancy (except adequately treated basal cell carcinoma or a squamous cell skin carcinoma, superficial bladder carcinoma, or any other in situ carcinoma currently in complete remission) within 5 years of randomization.\n* Known allergies, hypersensitivity or intolerance to the excipients of Apalutamide.\n* Patients who, within 28 days prior to randomisation, have received:\n\n  1. transfusions (red blood cells and\u002For platelets);\n  2. hematopoietic growth factors;\n  3. major surgery.\n* Symptomatic and\u002For chronic viral hepatitis; chronic liver disease; moderate or severe liver failure (class B and C according to the Child-Pugh scale); encephalopathy, ascites or thrombo-haemorrhagic disorders secondary to liver failure.\n* Gastrointestinal disorders affecting drug absorption\n* Active infections requiring systemic therapy such as human immunodeficiency virus (HIV);\n* Any condition or situation which, in the judgment of the investigator, precludes participation in this trial.\n\nExclusion criteria for cytoreductive surgery:\n\n* Contraindication for surgery",{"count":347,"type":20},566,[349],"NA","Italian multicenter study, will enroll \\~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide.\n\nAfter 6 months from the start of treatment, patients will be randomized to receive local treatment based on the investigator's choice ( either one between primary radiotherapy or cytoreductive prostatectomy), in addition to apalutamide, or to continue just with medical therapy.",[83],"2025-09-02",{"date":354,"type":34},"2025-09-03",{"date":356,"type":34},"2023-03-01",{"date":358,"type":20},"2029-01-01",{"name":360,"class":120},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",3,{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":21,"phases":372,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":390},"100355122","phase-3-probio-a-biomarker-driven-study-in-patients-with-metastatic-prostate-cancer-100355122","NCT03903835","ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer","ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer","ProBio","Inclusion Criteria:\n\n* Man with histologically confirmed prostate adenocarcinoma, initiating systemic therapy for metastatic disease, encompassing newly diagnosed (i.e. de novo) hormone sensitive prostate cancer (mHSPC) or first-line castration resistant prostate cancer (mCRPC)\n* Distant metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI\n* Adequate health as assessed by the investigator to receive all available treatments in the trial\n* ECOG\u002FWHO (Eastern Cooperative Oncology Group\u002F World Health Organization) performance score 0-2\n* Adequate organ and bone marrow function\n* Albumin greater than or equal to 28 g\u002FL\n* Able to understand the patient information and sign written informed consent\n\nExclusion Criteria:\n\n* Other malignancies within 5 years except non-melanoma skin cancer\n* Within 6 months of randomization: myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke, TIA (transient ischemic attack), or congestive heart failure NYHA (New York Heart Association) class III or IV\n* Uncontrolled hypertension\n* Uncontrolled hypotension\n* Received systemic therapy (with the exception of standard ADT) prior to study inclusion, for the CRPC indication\n* Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results\n* Unable to comply with study procedures\n* Current participation in another clinical trial that will be in conflict with the present study, administration of an investigational therapeutic or invasive surgical procedure within 28 days prior to study enrolment\n* Patients who are unlikely to comply with the protocol\n* Any condition or situation which, in the opinion of the investigator, would put the subject at risk, may confound study results, or interfere with the subjects participation in this study.\n* Any medical condition that would make use of the study treatments contraindicated, according to the SmPC, e.g. significant heart or liver disease.",{"count":371,"type":20},750,[233],"ProBio is an international, outcome-adaptive, multi-arm, open-label, multiple assignment randomized biomarker driven platform trial in patients with metastatic prostate cancer. Patients will be randomized to control or experimental treatment arms. Patients in the control arm will receive standard of care following national guidelines. Patients in the experimental arm will be randomized to treatments based on a biomarker signature inferred from diagnostic tissue or liquid biopsy profiling. The predefined biomarker signatures are tumor properties or mutations in genes\u002Fpathways with previously demonstrated clinical validity (e.g. prognostic value or association with treatment response). The biomarker signatures are identified using a hybridisation capture gene panel specifically designed for prostate cancer.",[375,83],"Metastatic Castration-resistant Prostate Cancer (mCRPC)",[377,58,378,379,380],"mCRPC","cfDNA","Genomics","Liquid Biopsy","2025-04-07",{"date":383,"type":34},"2025-04-09",{"date":385,"type":34},"2019-02-01",{"date":387,"type":20},"2026-12",{"name":389,"class":120},"Karolinska Institutet",32,{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":21,"phases":399,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":68},"100512760","phase-3-comparing-a-6-month-vs-long-term-course-of-rezvilutamide-with-adt-plus-chemotherapy-in-mhspc-100512760","NCT05956639","Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC","A Multi-center, Randomized, Open-label Clinical Trial Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in High Tumor Burden mHSPC","Inclusion Criteria:\n\n* Inclusion criteria:\n\n  1. Age ≥ 18 years, male.\n  2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n  3. Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine or small cell features.\n  4. High tumor burden, defined as having at least one of the following conditions: 1) Bone scan showing ≥4 bone metastatic lesions (with at least one site outside the pelvis or spine). 2) CT\u002FMRI revealing visceral metastatic lesions (excluding lymph nodes).\n  5. Planned to receive or maintain androgen deprivation therapy (ADT) during the study period, either by continuous LHRHa treatment or previous bilateral orchiectomy (surgical castration), concurrently with 6 cycles of docetaxel chemotherapy.\n  6. Organ function levels must meet the following requirements:\n\n     * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL.\n     * Platelets (PLT) ≥ 100 × 10\\^9\u002FL.\n     * Hemoglobin (Hb) ≥ 90 g\u002FL.\n     * Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN).\n     * Alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n     * Aspartate aminotransferase (AST) ≤ 2.5 × ULN.\n     * Blood urea nitrogen (BUN) (or urea) and creatinine (Cr) ≤ 1.5 × ULN.\n     * Left ventricular ejection fraction (LVEF) ≥ 50%.\n  7. Judged by the investigator to be able to comply with the trial protocol.\n  8. Voluntarily participate in the clinical trial, understand the study procedures, and have signed the informed consent form.\n\nExclusion Criteria:\n\n1. Prior treatment with ADT, chemotherapy, surgery, external beam radiation therapy, brachytherapy, radiopharmaceuticals, or investigational local therapies for prostate pain. However, the following cases are allowed for inclusion:\n\n   * Up to 3 months of ADT (medical or surgical castration) with or without antiandrogen therapy prior to Cycle 1 Day 1 (C1D1) without evidence of radiographic disease progression (based on RECIST 1.1 criteria) or clinically significant PSA rise (defined as ≥50% increase from the lowest level after reaching castration levels of serum testosterone) before C1D1.\n   * Transurethral prostatectomy or up to one course of palliative radiation therapy or surgery for symptomatic treatment of metastatic disease at least 4 weeks prior to C1D1. All adverse events related to these treatments must have improved to at least Grade 1 (according to NCI-CTCAE v4.03) before starting study treatment.\n2. Prior use or planned use of second-generation androgen receptor antagonists (such as enzalutamide, apalutamide, darolutamide), abiraterone acetate, or other investigational drugs inhibiting testosterone synthesis for the treatment of prostate cancer during the study period.\n3. Received the following treatments within 4 weeks before C1D1:\n\n   * 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride).\n   * Estrogens, progestins, androgens, systemic corticosteroids (except for temporary use for allergic purposes).\n   * Known herbal medicines with anti-prostate cancer or PSA-lowering effects (e.g., saw palmetto).\n   * Participation in other clinical trials involving investigational treatments.\n4. Confirmed brain tumor lesions on imaging.\n5. Planned to receive any other anticancer treatment during the trial.\n6. Known allergy or hypersensitivity to apalutamide, ADT, or chemotherapy components.\n7. Presence of conditions that impede swallowing, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.\n8. History of seizures or occurrence of conditions that can induce seizures within 12 months before C1D1 (including transient ischemic attack, stroke, traumatic brain injury with altered consciousness requiring hospitalization).\n9. Presence of active cardiac diseases within 6 months before C1D1, including severe\u002Funstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medication.\n10. Diagnosis of any other malignancy within 5 years before C1D1, except for completely resolved in situ cancer or malignancies with slow progression as determined by the investigator.\n11. Active HBV or HCV infection (HBV viral load ≥ 10,000 copies\u002FmL, HCV viral load ≥ 1,000 copies\u002FmL).\n12. History of immunodeficiency (including positive HIV test) or organ transplantation.\n13. Unwillingness to use effective contraception during the entire study treatment period and for 30 days after the last dose.\n14. Judged by the investigator to have conditions that pose a serious risk to patient safety, may confound study results, or may affect the patient's ability to complete the study (such as poorly controlled hypertension, severe diabetes, neurological or psychiatric diseases, etc.), or any other relevant circumstances.",{"count":52,"type":20},[233],"Primary Objective:\n\nTo explore whether a 6-month course of Rezvilutamide in the triple therapy regimen is non-inferior to long-term Rezvilutamide treatment in improving radiographic progression-free survival (rPFS) in patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC).\n\nSecondary Objectives:\n\nTo evaluate and compare the time to prostate-specific antigen (PSA) progression, time to next bone-related event, time to initiation of subsequent anti-prostate cancer treatment, and objective response rate (ORR) between the 6-month and long-term course of Rezvilutamide with androgen deprivation therapy (ADT) plus docetaxel in patients with high tumor burden mHSPC.\n\nTo assess and compare the incidence of adverse events between the 6-month and long-term course of Rezvilutamide with ADT plus docetaxel in patients with high tumor burden mHSPC.\n\nExploratory Objectives:\n\nTo observe the circulating tumor cell status at 6 months, 12 months, 18 months, and 24 months in patients with high tumor burden mHSPC receiving the triple therapy regimen.",[83],[403,404,326],"Triple treatment regimen","mHPSC","2023-07-13",{"date":407,"type":34},"2023-07-21",{"date":409,"type":34},"2023-06-20",{"date":411,"type":20},"2027-12-31",{"name":413,"class":120},"The First Affiliated Hospital with Nanjing Medical University"]