[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer-metastatic-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer-metastatic-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,41,74,101,128,170,190,229,255,282,307,334,359],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100567988","phase-2-using-fapi-petmri-to-evaluate-prostate-cancer-100567988",false,"NCT06675357","Using FAPI PET\u002FMRI to Evaluate Prostate Cancer","Novel FAP-targeted Approach to Imaging Patients With or High-risk for Metastatic Prostate Cancer","Inclusion Criteria:\n\n* Age 18 years or older\n* Able and willing to provide informed consent\n* Known diagnosis of prostate cancer\n* Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET\n* Optional: Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases.\n* Willing and able to undergo PET\u002FMRI as part of this research\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent\n* Contraindication(s) to or inability to undergo PET\u002FMRI\n* Participants for whom PET\u002FMRI will delay timely delivery of treatment\n* Participants requiring intravenous (IV) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:\n* Have their own prescription for the medication\n* The informed consent process is conducted prior to the self-administration of this medication\n* Come to the research visit with a driver","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to gain more information about how FAPI (fibroblast activation protein inhibitor) binds to certain type of cells in the tumor tissue. The main question it aims to answer is how this information can be used to better diagnose and track prostate cancer.\n\nParticipants will undergo two PET\u002FMRI scans during two research visits, each of which may last up to 2.5 hours.",[26,27],"Prostate Cancer Metastatic Disease","Prostate Cancers","RECRUITING","2026-06-09",{"date":31,"type":32},"2026-06-10","ACTUAL",{"date":34,"type":32},"2026-02-27",{"date":36,"type":20},"2027-01",{"name":38,"class":39},"University of Wisconsin, Madison","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100642906","patients-with-metastasized-prostate-cancer-whose-prostate-specific-antigen-level-psa-remains-02-ngml-after-six-months-of-dual-antihormonal-therapy-will-receive-radiotherapy-to-the-prostate-and-radiotherapy-to-refractory-metastases-100642906","NCT07644754","Patients With Metastasized Prostate Cancer Whose Prostate-specific Antigen-level (PSA) Remains >0,2 ng\u002Fml After Six Months of Dual Antihormonal Therapy Will Receive Radiotherapy to the Prostate and Radiotherapy to Refractory Metastases","RIALTO: Radiotherapy in Primarily Metastasized Prostate Cancer - Image-guided Local AbLaTion of Prostate and Oligoresidual Disease","RIALTO","Inclusion Criteria:\n\n* Prostate adenocarcinoma\n* de novo metastasized prostate cancer (at least 4 osseous metastases +\u002F- lymphonodal metastases)\n* first-line combined antihormonal therapy (ADT + ARPI) for six months\n* PSA \\> 0,2 ng\u002Fml after six months of combined ADT\u002FARPI therapy\n* multimetastasized disease stage without visceral metastases on imaging at first diagnosis (PET, CT, or bone scan)\n* \\\u003C16 osseous\u002Flymphnodal metastases on response assessment imaging (PSMA-PET\u002FCT) after six months of combined antihormonal therapy\n\nExclusion Criteria:\n\n* neuroendocrine histology\n* visceral metastases (M1c)\n* prior radiotherapy to the pelvis\n* PSA \\\u003C 0,2 ng\u002Fml after 6 months of combined antihormonal therapy\n* prior prostatectomy\n* contraindication against PSMA-PET\u002FCT and\u002For radiotherapy to the prostate\u002Fmetastases\n* HIFU or TUR-P within 6 months of study treatment\n* other active malignancy two years prior to study inclusion (except skin cancer in remission)\n* relevant GU\u002FGI condition (active fistula or other)\n* known tumor predisposition syndrome","MALE","85 Years",{"count":52,"type":20},27,[54],"NA","The goal of this clinical trial is to learn if radiotherapy to the prostate and PET-positive (positron emission tomography) metastasis will lead to radiological response on PSMA-PET (prostate specific membrane antigen-PET). Patients who receive combined androgen deprivation therapy for de novo metastasized prostate cancer and show an incomplete PSA-response (\\>0,2 ng\u002Fml after six months) and exhibit at least four bone metastases on PET-imaging at this time point (without metastases to organs) can take part in this study.\n\nThe main questions it aims to answer are:\n\n• Does radiotherapy to the prostate and PET-positive metastases lead to a radiological response one year after radiotherapy? Researchers will analyze PET-imaging prior to radiotherapy to the prostate and metastases and one yeare thereafter.\n\nParticipants will:\n\n* Continue taking combined androgen-deprivation therapy\n* Receive a total of three PSMA-PET\u002FCT scans\n* Receive radiotherapy to the prostate and PET-positive metastases\n* Visit the clinic every three months for 36 months\n* Complete quality of life questionnaires at every visit",[57,26,58],"Prostate Cancer","Prostate Cancer Metastatic to Bone",[60,61,62,63],"mHSPC","insufficient PSA-response to dual antihormonal treatment","local therapy","radiotherapy","NOT_YET_RECRUITING","2026-06-08",{"date":67,"type":32},"2026-06-12",{"date":69,"type":20},"2026-07",{"date":71,"type":20},"2031-02",{"name":73,"class":39},"University Hospital Tuebingen",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":40},"100591274","highly-metastatic-life-prolonging-therapy-resistant-prostate-cancer-role-of-stereotactic-radiotherapy-for-bone-and-lymph-node-metastases-himars-100591274","NCT06978296","HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases (HIMARS)","HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases","HIMARS","Inclusion Criteria:\n\n* Metastatic prostate cancer with clinical progression after the use of androgen-receptor pathway inhibitor, chemotherapy or any other life-prolonging therapy. Patient could have been treated previously by RadioLigand Therapy (RLT).\n* Performance Status \\\u003C 3\n* Bone and\u002For lymph node metastases based on conventional (CT and bone scan) or metabolic imaging\n* Bone and\u002For lymph node metastases suitable for SRT, according to the investigator\n* Adequate organ function:\n\n  1. Absolute Neutrophil Count (ANC) ≥ 1000\u002Fmm3 or\n  2. Platelet Count ≥ 50 000\u002Fmm3 or\n  3. Haemoglobin ≥ 8 g\u002FdL (allowing transfusion or other intervention to achieve this minimum haemoglobin)\n* Age ≥ 18 years at time of study entry\n* Written informed consent obtained from the patient prior to performing any protocol-related\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Patient has valid health insurance\n* Life time expected \\> 3 months\n\nExclusion Criteria:\n\n* Evidence of symptomatic metastases to the lungs, brain, peritoneum or liver\n* Evidence of diffuse metastatic spread to the bone marrow (e.g. positive super bone scan) or the cerebral spinal fluid as per bone scan (no lumbar puncture required).\n* Evidence of presence of symptomatic spinal cord compression with indication of neurosurgical decompression.\n* Patient with symptomatic and\u002For high-risk tumor volume-to-bone marrow reserve ratio \\> 50%\n* Concurrent enrolment in another clinical study, unless it is a non-therapeutic clinical study\n* Mental impairment (psychiatric illness\u002Fsocial situations) that may compromise the ability of the patient to give informed consent and comply with the requirements of the study;\n* Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship;\n* Patients unable to undergo medical follow-up in the study for geographical, social or psychological reasons.\n* History of another primary malignancy except for\n\n  1. Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of SRT and of low potential risk for recurrence\n  2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  3. Adequately treated carcinoma in situ without evidence of disease\n* Uncontrolled pain that contraindicates patient positioning on the radiotherapy table according to investigator\n* Patient indicated to or currently treated by cytopenic treatment as chemotherapy or RadioLigand Therapy\n* Patient under concomitant treatment that may generate severe gastro-intestinal disorder or genito-urinary disorder",{"count":83,"type":20},18,[54],"The investigators propose redefining this concept by focusing on volume rather than the number of metastases. To achieve this, the investigators aim to determine the Maximum Tolerated Volume (MTV) of metastatic lesions treatable with SRT (Stereotaxic radiotherapy) in a phase 1 study. In this study, the investigators will recruit patients with high-volume metastatic disease in bones or lymph nodes and progressively irradiate a volume-escalated subset of the total lesions. The selection will prioritize lesions at higher risk of causing pain or complications, such as fractures, spinal compression, or vascular compression. The investigators hypothesis is that SRT targeting multiple metastases (with a total volume ≤ MTV) will extend the duration without refractory pain and\u002For tumor-related complications in patients with castration-resistant and chemo-refractory prostate cancer.",[26,87],"Oligometastatic Prostate Cancer (OMPC)",[89,90,91],"Radiotherapy","Stereotaxic","oligometastatic","2026-06-02",{"date":94,"type":32},"2026-06-04",{"date":96,"type":32},"2026-06-01",{"date":98,"type":20},"2030-07-01",{"name":100,"class":39},"Institut Cancerologie de l'Ouest",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100581379","phase-2-phase-ii-trial-to-investigate-the-safety-and-efficacy-of-four-dosing-regimens-of-otl78-injection-100581379","NCT06849544","Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection","Phase II Trial to Investigate the Safety and Efficacy of Four Dosing Regimens of OTL78 Injection (Zopocianine), a Prostate-Specific Membrane Antigen (PSMA)-Targeted Fluorescent Agent, for the Intraoperative Imaging of Prostate Cancer","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent and HIPAA form\n2. Male subjects 18 years of age and older\n3. Known primary prostate cancer and Grade Group 3 to 5 (≥ cT3) or one or more of the following:\n\n   1. Suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and\u002For seminal vesicle infiltration (SVI)),\n   2. 3 or more biopsy cores of grade group 3-5;\n   3. Suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+));\n4. Planned to undergo a standard of care robotic prostatectomy and lymph node dissection\n5. Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments\n6. Agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including through final study visit (6 weeks) after the dose of study drug. Sperm donation is prohibited during the study and for 3 months after the dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.\n\nExclusion Criteria:\n\n1. The surgeon plans to perform an extraperitoneal approach\n2. History of anaphylactic reactions to products containing indocyanine green\n3. History of allergy to any of the components of ZOPOCIANINE:\n\n   1. 2-\\[3-(1,3-dicarboxypropyl)ureido\\] pentanedioic acid (DUPA)\n   2. Polyethylene glycol-dipeptide linker\n   3. Chlorodye\n4. Impaired renal or hepatic function:\n\n   1. Renal: creatinine clearance (eGFR) \\\u003C 50 mL\u002Fmin\n   2. Hepatic: total bilirubin \\> 2 × upper limit of normal or ALT\u002FAST \\> 3 × upper limit of normal.\n5. Patients with QTc interval ≥ 470 msec per electrocardiogram (ECG) at screening.\n6. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and\u002For compromise the objectives of the study",{"count":109,"type":20},22,[23],"This study is being done to compare how well Zopocianine (OTL78) in combination with Near InfraRed (NIR) fluorescent imaging may improve the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.",[113,26],"Prostate Cancer Surgery",[115,116,117],"Prostate Specific Membrane Antigen","Fluorescent Imaging","Near infrared imaging","2026-04-30",{"date":120,"type":32},"2026-05-05",{"date":122,"type":32},"2025-04-02",{"date":124,"type":20},"2026-08",{"name":126,"class":39},"Clinton Bahler",3,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":127},"100593295","lab-research-using-mini-tumors-to-study-prostate-cancer-treatments-100593295","NCT07004582","Lab Research Using Mini-tumors to Study Prostate Cancer Treatments","Preclinical ex Vivo Patient-derived 3D Cultures for the Prediction of Prostate Cancer Treatment Response","PR3DICT","Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Patients with prostate cancer\n* Patients planned for HDR brachytherapy treatment for high-risk or recurrent prostate cancer or transperineal prostate biopsy with MRI-suspected metastatic prostate cancer with at least clinical stage T3-4.\n\nExclusion Criteria:\n\n* Patients younger than 18 years\n* Patients of whom it is not possible to obtain left-over tissue as part of the normal clinical treatment procedure (e.g., if all tumor material is required for the pathologist to make a diagnosis, to stage the patient or to perform a molecular diagnosis).",{"count":137,"type":20},600,"OBSERVATIONAL","For men with an aggressive form of prostate cancer, finding the right and effective treatment right away is challenging. Many of these men face a high risk of cancer recurrence: about half experience a relapse after surgery, and more than a third after undergoing radiation therapy. Men with metastatic prostate cancer have particularly poor prognoses, with a five-year survival rate of only 30% to 50%. In short, it is difficult to predict which treatment, or combination of treatments, will lead to longer survival for this group of men with aggressive (metastatic) prostate cancer.\n\nIn the laboratory, it is possible to grow small samples of tumors into 3D mini-tumors. These mini-tumors retain the characteristics of the patient's original tumor tissue. Various treatments can be tested on these 3D mini-tumors to determine which therapy is most effective for each individual case. There are currently two techniques available for creating these 3D mini-tumors in the lab. In this project, we aim to investigate which of these two techniques works best in order to test and personalize treatments.",[57,26,141,142],"Prostate Cancer Recurrent","Advanced Prostate Cancer",[144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160],"Advanced prostate cancer","Metastatic prostate cancer","Prostate cancer","Patient-tailored treatment","Precision Medicine","Ex vivo prediction platform","Personalized medicine","Drug Screening Assays","Three-Dimensional Culture Techniques","Organoids","Tumoroids","Tumor replicas","Prostatic Neoplasms","Neoplasm Metastasis","Advanced Cancer","Treatment Outcome","Human Tissue Culture Techniques","2026-04-20",{"date":163,"type":32},"2026-04-23",{"date":165,"type":32},"2026-03-15",{"date":167,"type":20},"2031-12-30",{"name":169,"class":39},"Maastricht Radiation Oncology",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":40},"100580090","phase-2-exploration-of-treatment-effect-of-novel-hormone-therapy-combined-with-local-treatment-based-on-psma-petct-evaluation-in-mhscp-patients-100580090","NCT06832774","Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET\u002FCT Evaluation in mHSCP Patients","Inclusion Criteria:\n\n1. Male patients over the age of 18;\n2. The physical condition (PS) score of the Eastern Cooperative Oncology Group (ECOG) is 0, 1, or 2 points;\n3. Expected lifespan \\>2 years;\n4. All newly diagnosed patients with metastatic prostate cancer (mHSPC, metastatic hormone sensitive prostate cancer) diagnosed by PSMA PET\u002FCT, and still present active lesions on PSMA PET\u002FCT after receiving new endocrine therapy;\n5. Has not received any other treatment for prostate cancer before;\n6. No significant organ dysfunction upon evaluation;\n7. Agreed to sign the written consent form for this study, indicating a comprehensive understanding of the purpose and process of this study, and willingness to participate in this study.\n\nExclusion Criteria:\n\n1. A medical history of any other active malignant tumor within 2 years (excluding fully treated basal cell or squamous cell skin cancer, superficial bladder cancer or any other cancer in situ that is currently in complete remission);\n2. Prostate biopsy shows sarcomatoid cells, ductal carcinoma, or neuroendocrine cell components;\n3. Severe complications, immune suppression, severe mental illness, severe activity restriction, or inability to comply with this study;\n4. Currently participating in other clinical trials for prostate cancer;\n5. According to the researcher's judgment, there are conditions that are not in line with the best interests of the subjects participating in the study, or may hinder, limit, or interfere with the study protocol.",{"count":177,"type":20},192,[23],"At present, there is still controversy over the treatment of metastatic hormone sensitive prostate cancer (mHSPC). Major guidelines and consensus suggest that novel hormone therapy (NHT) should be used as the basic treatment for mHSPC, and metastasis directed therapy can be combined depending on the clinical situation. However, it is still unclear how to develop more specific and individualized treatment plans for mHSPC patients. On the other hand, prostate-specific membrane antigen (PSMA) which is highly specifically expressed in prostate epithelial cells has been widely used as a PET\u002FCT target for the diagnosis and staging of prostate cancer. However, there is still a lack of clinical evidence on how to use it to guide the treatment of prostate cancer. Therefore, this study intends to include patients diagnosed with mHSPC by PSMA PET\u002FCT. The patients received no prior treatment for prostate cancer or ADT plus NHT therapy only. After 8 months of ADT plus NHT, PSMA PET\u002FCT will be re-evaluated and patients with remaining active lesions on PSMA PET\u002FCT will be included for randomization. The aim of this study is to explore the effect of NHT combined with local treatment on delaying disease progression and prolonging survival in patients with active lesions on PSMA PET\u002FCT after NHT, providing new insights into the treatment of mHSCP patients.",[26],"2026-03-20",{"date":183,"type":32},"2026-03-25",{"date":185,"type":32},"2025-08-01",{"date":187,"type":20},"2028-12-31",{"name":189,"class":39},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":49,"minAge":198,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":21,"phases":201,"briefSummary":202,"conditions":203,"keywords":220,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":227,"locationsCount":40},"100589690","phase-2-proof-of-concept-trial-to-assess-the-efficacy-and-safety-of-fezolinetant-in-improving-vasomotor-symptoms-in-men-with-prostate-cancer-undergoing-androgen-deprivation-therapy-100589690","NCT06957691","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy (Fezo-ADT Trial)","Fezo-ADT","Inclusion Criteria:\n\n* Male sex\n* Age 40 years and older\n* Diagnosis of prostate cancer\n* Androgen deprivation therapy\n* Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week\n* Ability to sign the inform consent\n* Willing to use reliable methods of contraception if partner is of childbearing age\n* Ability to record hot flashes electronically\n\nExclusion Criteria:\n\n* Use of abiraterone acetate\n* Use of docetaxel and other chemotherapeutic agents\n* Liver cirrhosis\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal\n* Total bilirubin above the upper limit of normal\n* Glomerular filtration rate \\\u003C 30 mL\u002Fmin\n* Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics\n* Use of over-the-counter hormonal agents or herbal compounds\n* Current use of CYP1A2 inhibitors\n* Ingestion of alcohol within 2 weeks prior to the baseline visit\n* Inability to abstain from alcohol use during the study period.","40 Years",{"count":200,"type":20},60,[23],"The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy.\n\nThe main questions it aims to answer are:\n\n* Does fezolinetant improve the frequency and severity of hot flashes?\n* Does fezolinetant cause any harm to the liver?\n* Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters?\n\nResearchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine.\n\nParticipants will:\n\n* Take fezolinetant or a placebo every day for 4 weeks\n* Visit the clinic once every 2 weeks for checkups and tests\n* Keep a diary of the number of times and intensity that they experience hot flashes",[57,204,26,141,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219],"Prostate Cancer (Adenocarcinoma)","Prostate Carcinoma","Prostate Neoplasm","Prostate Adenocarcinoma","Prostate Cancer With Bone Metastasis","Vasomotor Disturbance","Vasomotor Symptoms","Vasomotor Symptoms (VMS)","Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","Vasomotor Symptoms; Hot Flashes","Androgen Deprivation Therapy","Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma","Androgen-deprivation Therapy","Hot Flashes","Hot Flushes","Hot Flushes and\u002For Sweats",[214,217,218,57,210],"2026-03-05",{"date":223,"type":32},"2026-03-09",{"date":225,"type":32},"2026-01-14",{"date":187,"type":20},{"name":228,"class":39},"Shehzad Basaria, M.D.",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":21,"phases":238,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":40},"100601854","psma-pet-for-surveillance-after-focal-therapy-100601854","NCT07115914","PSMA PET for Surveillance After Focal Therapy","Prospective Evaluation of PSMA PET Imaging in Surveillance Post-Focal Therapy for Prostate Cancer (PSMA-FT Surveillance Study)","Inclusion Criteria:\n\n1. Subjects must be male (assigned male at birth) and 18 years or older.\n2. Subjects must demonstrate the ability to understand and provide written informed consent.\n3. Subjects must have histologically confirmed prostate cancer ( PCa) Note: Recruitment will be limited to a maximum of 50% of subjects with favorable intermediate-risk prostate cancer (PCa) Note: The histopathologic diagnosis must be obtained via \"Prostate Biopsy (PB)\", which for the purposes of the present study, is defined as both a systematic 12-core sextant random prostate biopsy and a targeted prostate biopsy. The targeted prostate biopsy can be performed via in-bore multiparemetric (mp) magnetic resonance imaging (MRI) prostate biopsy, cognitive mpMRI\u002Fultrasound fusion prostate biopsy or software mpMRI\u002Fultrasound fusion prostate biopsy. This \"PB\" must not be obtained greater than 1 year from the date of consent.\n4. Subjects must have chosen to get focal therapy (partial gland ablation) for the treatment of prostate cancer and must be scheduled for partial gland ablation\u002Ffocal therapy with any energy modality within 6 months following informed consent.\n5. Subjects must have confirmed non-metastatic PCa following SOC screening for patients with unfavorable intermediate-risk and high risk PCa, a combination of computed tomography imaging of the abdomen and pelvis (CTAP) and technetium-99-mDP nuclear medicine bone scan (BS) and\u002For PSMA-PET imaging prior to enrollment. The imaging studies should be obtained within 6-months of enrollment.\n6. Subjects must be designated as Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky Performance Status Scale Score ≥ 60%, (see Appendix A).\n7. Subjects must be fit to undergo general anesthesia and the FT surgical procedure, which includes adequate visualization of the prostate gland on transrectal ultrasound imaging, access to the urethra, perineum and rectum, as well as be tolerant of lithotomy positioning in the opinion of the treating investigator or the operating surgeon(s) if not the same as the treating investigator.\n\nExclusion Criteria:\n\n1. Subject had prior or current PCa therapies, such as biologic, chemotherapy, hormone therapy, radiotherapy or surgery for PCa within last 12 months. Subjects who received radiation and\u002For androgen deprivation therapy for prostate cancer more than 12 months prior to diagnosis of recurrent prostate cancer will be eligible for the trial.\n2. Subjects with locally advanced, nodal or metastatic prostate cancer.\n3. Subjects who are unfit for pelvic mpMRI scanning (e.g., severe claustrophobia), permanent cardiac pacemaker, metallic implants that are likely to contribute to significant image artifacts, allergy or contraindication to gadolinium contrast agent.\n4. If the subject has an uncontrolled or major debilitating inter-current illness.\n5. Judgment by the treating investigator or PI that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.",{"count":237,"type":20},62,[54],"This study is about adding PSMA PET (Prostate Specific Membrane Antigen- Positron Emission Tomography) to routine magnetic resonance imaging (MRI) scans to help detect prostate cancer recurrence in men who have undergone focal therapy for prostate cancer. PSMA PET and multiparametric (mpMRI are both imaging tests that help detect prostate cancer in the body.\n\nA PSMA PET scan, or prostate-specific membrane antigen positron emission tomography scan, is an imaging test that scans and takes pictures of the prostate. PSMA scans use a specialized radioactive imaging dye that sticks to the proteins that are typically found in prostate cancer cells. This imaging dye helps locate areas of prostate cancer anywhere in the body, both inside and outside prostate.\n\nAn mpMRI, or a multiparametric (mp) MRI scan, is also an imaging test that scans and takes detailed pictures of the prostate. Unlike regular MRIs, an mpMRI produces a more detailed image of the prostate. Similar to PET scans, mpMRI scans also use an imaging dye that helps the pictures of the prostate appear clearer on scans.\n\nThis study will be funded by Blue Earth Diagnostics, a molecular imaging company based in England.",[204,241,26],"Prostate Cancer (Diagnosis)",[243,244,245],"focal therapy","prostate cancer","prostate cancer patient","2026-02-13",{"date":248,"type":32},"2026-02-17",{"date":250,"type":32},"2025-11-19",{"date":252,"type":20},"2028-08-01",{"name":254,"class":39},"University of Chicago",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":264,"studyType":138,"phases":4,"briefSummary":265,"conditions":266,"keywords":267,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":40},"100579743","prospective-evaluation-of-imaging-response-biomarkers-during-177lulu-psma-in-metastatic-castration-resistant-prostate-cancer-100579743","NCT06828263","Prospective Evaluation of Imaging Response Biomarkers During [177Lu]Lu-PSMA in Metastatic Castration-resistant Prostate Cancer","68Ga-PSMA","Inclusion Criteria:\n\n* Adult aged 18 or older with proven adenocarcinoma of the prostate\n* Diagnosis of progressive metastatic castration-resistant prostate cancer.\n* Progression or intolerance on a novel anti-androgen therapy (i.e. abiraterone, enzalutamide, apalutamide or darolutamide)\n* Prior therapy with at least one taxane-based chemotherapy during the course of prostate cancer or the patient is symptomatic and assessed as unfit for chemotherapy.\n* ECOG Performance status 0 to 2\n\nExclusion Criteria:\n\n* Patient opposed to the use of his data for clinical research.",{"count":263,"type":20},130,"12 Months","Lutetium-177 (177Lu) prostate-specific membrane antigen (177Lu-PSMA) is a radiolabelled small-molecule inhibitor that binds with high affinity to PSMA and delivers β particle radiation. \\[177Lu\\]Lu-PSMA-617 (Pluvicto) was approved by the U.S. Food and Drug administration (FDA) in patients with late-stage, PSMA positive metastatic castration-resistant prostate cancer (mCRPC) based on the results from the phase 3 VISION trial \\[1\\].\n\nEarly identification of tumor progression may reduce unnecessary therapy cycles and their associated risk of adverse events as well as reducing costs and improving patient care by initiating an earlier change in treatment towards a possibly more efficacious therapy.\n\nResponse Evaluation Criteria In PSMA-imaging (RECIP) version 1.0 is an evidence-based framework to evaluate therapeutic efficacy in metastatic prostate cancer using PSMA-imaging\\[2,3\\]. Interim PSMA-PET\u002FCT by RECIP 1.0 criteria performed at 10 weeks after two cycles of PSMA theranostics (\\[177Lu\\]Lu-PSMA- 617 or \\[177Lu\\]Lu-PSMA-I\\&T) is prognostic for overall survival\\[2\\]. RECIP 1.0 criteria were validated based on overall survival outcome for measuring response in metastatic prostate cancer during androgen receptor-signaling inhibitors\\[4\\], as well as in early-stage prostate cancer in patients with biochemical recurrence after initial therapy\\[5\\].\n\nLutetium-177 is a beta therapy that also emits 11% gamma rays, which can be utilised to derive whole-body tomographic images similar to PSMA-PET\u002FCT. Serial Lutetium-177 PSMA-targeted single photon emission tomography\u002Fcomputed tomography \\[177Lu\\]Lu-PSMA-SPECT\u002FCT henceforth referred to as LuPSMASPECT\u002F CT has potential as an imaging response biomarker for 177Lu-PSMA therapy. This principle enables image quantitation and evaluation after every treatment dose. SPECT\u002FCT post \\[177Lu\\]Lu-PSMA administration represents a potentially cost-effective alternative to interim PSMA-PET\u002FCT.\n\nPreliminary results have shown a good correlation between changes in LuPSMASPECT\u002F CT during PSMA theranostics and clinical outcome. LuPSMA-SPECT\u002FCT can provide effective response information as early as 6 weeks after initiation of \\[177Lu\\]Lu-PSMA-I\\&T, i.e. any increase in total tumor volume on SPECT\u002FCT imaging was associated with shorter PSA-PFS (median: 3.7 vs 6.7 months; HR, 2.5; 95% CI 1.5-4.2; p\\\u003C0.001)\\[6\\]. Changes in total tumor volume on 12-week LuPSMASPECT\u002F CT were also found to be correlated with progression-free survival after \\[177Lu\\]Lu-PSMA-I\\&T\\[7\\].\n\nThe growing evidence suggesting that LuPSMA-SPECT\u002FCT is a new, early surrogate marker for assessing response to treatment has several potential upsides, including the potential replacement of interim PSMA-PET\u002FCT, therefore costsaving, radiation exposure-saving, and SPECT\u002FCT imaging being more convenient and widely available.\n\nGiven that data regarding SPECT\u002FCT-based treatment response monitoring during PSMA theranostics are limited, this study aims to prospectively investigate the role of LuPSMA-SPECT\u002FCT imaging for response evaluation during treatment with \\[177Lu\\]Lu-PSMA in mCRPC patients.",[26],[268,269,270,271,272],"Prostate cancer metastatic disease","[177Lu]Lu-PSMA","metastatic castration-resistant prostate cancer","mCRPC","LuPSMA-SPECT\u002FCT imaging","2025-12-18",{"date":275,"type":32},"2025-12-26",{"date":277,"type":32},"2023-08-01",{"date":279,"type":20},"2043-12",{"name":281,"class":39},"University Hospital, Grenoble",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100568527","role-of-race-in-nutritional-approach-in-men-on-adt-100568527","NCT06682390","Role of Race in Nutritional Approach in Men on ADT","Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy","Inclusion Criteria:\n\n* \\>12 months on ADT\n* Expected continuation of ADT for \\>6 months upon initiation of study procedures\n* Serum testosterone \\\u003C50 ng\u002FdL\n* BMI \\>25\n* Age \\>18 years old\n* African American and Non-Hispanic white males\n* Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C 1 year\n* Females\n* Radiation or chemotherapy treatment\n* History of diabetes or serious medical condition including uncontrolled hypertension, liver, kidney, and cardiovascular disease\n* Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator\n* Any subject who currently uses tobacco products\n* Any use of \\>20 g of alcohol per day\n* Any subject who is unable or unwilling to comply with the study protocol\n* Any subject who is unable to provide consent",{"count":290,"type":20},70,[54],"There is a well-documented association between androgen deprivation therapy (ADT) and cardiovascular morbidity. A majority of men on ADT gain weight contributing to an increase in cardiovascular risk factors (CVRFs) and cardiovascular morbidity. Dietary intervention combined with exercise have shown success in reducing weight\u002Ffat mass and improving cardiovascular risk factors (CVRF). There is little data on whether African American men would respond to diet and exercise interventions differently from non-Hispanic white men. We will conduct a pilot, controlled two-phase intervention study stratified by race to investigate the following objectives:\n\n1. Compare effect of a hypocaloric, anti-inflammatory diet on changes in fat mass between African- American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.\n2. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cardiovascular risk factors (body weight, lean body mass, waist-to-height ratio, blood pressure, lipids and HbA1C) and inflammatory markers (hs-CRP and cytokines) between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.\n3. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cancer-related fatigue and quality of life between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy.\n\nWe will enroll 35 African American and 35 non-Hispanic white men with prostate cancer undergoing ADT therapy. In phase 1, after baseline assessment, men will consume their habitual diet and continue their habitual activity level for 3 months. During phase 2, participants will be instructed to consume a hypocaloric (-500 kcal), anti- inflammatory diet and walk for 1 hour on 3 days per week for 3 months. At baseline, after phase 1 and 2 primary outcome (fat mass) and secondary outcomes (CVRF and inflammatory markers) and tertiary outcomes (cancer-related fatigue and quality of life) will be determined.",[26],[295,296],"ADT","cardiovascular risk factors","2025-12-08",{"date":299,"type":32},"2025-12-15",{"date":301,"type":32},"2024-03-28",{"date":303,"type":20},"2027-11-29",{"name":305,"class":39},"University of California, Los Angeles",2,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":40},"100571314","efficacy-and-tolerability-of-low-dose-enzalutamide-in-prostate-cancer-100571314","NCT06718647","Efficacy and Tolerability of Low-Dose Enzalutamide in Prostate Cancer","Efficacy and Tolerability of Low-Dose Versus Standard-Dose Enzalutamide in Advance Prostate Cancer: a Real-World Evidence Study","LODE","Inclusion Criteria:\n\n* Patients with histological diagnosis metastatic prostate cancer;\n* Enzalutamide therapy taken between 01\u002F08\u002F2014 and 31\u002F12\u002F2023;\n* Age ≥ 18 years;\n* Signed Informed consent.\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular disease for example cerebrovascular accidents (\\\u003C=6 months), myocardial infarction (\\\u003C=3 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF); uncontrolled hypertension or bradycardia\n* Patients who died within one month of starting treatment with Enzalutamide for all causes;\n* Uncontrolled concomitant diseases.",{"count":316,"type":20},150,"Prostate cancer is the most common cancer in men in the United States and the second leading cause of cancer-related mortality in males. Since 2014, its incidence has increased by 3% annually, primarily due to a rise in advanced-stage cases. In Italy, over 41.000 cases were diagnosed in 2023, with 8.200 deaths. Enzalutamide, an androgen receptor inhibitor, is effective in treating metastatic prostate cancer but often requires dose reductions to improve tolerability in frail patients. Recent studies have shown that lower doses (≤ 80 mg per day) can maintain efficacy while improving safety and tolerability, with outcomes comparable to the standard dose (160 mg per day) in terms of overall survival, progression-free survival, and prostate-specific antigen response.\n\nBased on the results observed in these studies, the investigators expect that in our retrospective cohort of patients with metastatic prostate cancer, those who received low doses of enzalutamide will have a 1 year progression-free survival comparable to the full dose. The investigators will also expect a lower rate of adverse events.",[26],[320,321,322,323,324,145],"Enzalutamide","Low-Doses","Prostatic neoplasms","Elderly","Adverse event","2025-07-11",{"date":327,"type":32},"2025-07-16",{"date":329,"type":20},"2025-09-01",{"date":331,"type":20},"2025-12-31",{"name":333,"class":39},"Monica Boitano",{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":21,"phases":344,"briefSummary":345,"conditions":346,"keywords":347,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":40},"100592346","phase-2-radiotherapy-or-surgery-combined-with-intense-androgen-deprivation-therapy-for-mcrpc-100592346","NCT06992232","Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC","Radiotherapy or Radical Prostatectomy Combined With Intense Androgen Deprivation Therapy for Newly Diagnosed Metastatic Prostate Cancer: A Multi-center Randomized Controlled Phase II Trial","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed prostate adenocarcinoma, with distant metastasis diagnosed by novel imaging modalities (PSMA PET\u002FCT or PSMA PET\u002FMR), involving ≤10 metastatic sites (amenable to local therapy) and without visceral metastasis.\n2. The primary lesion is deemed resectable, or can achieve a resectable state following IADT.\n3. Non-castration range (≥50 ng\u002Fdl), or the duration of testosterone levels in the castration range is no more than 3 months.\n4. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.\n5. Patients must have adequate hematologic function, hepatic function and renal function.\n6. Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.\n7. Fertile patients must be willing to use highly effective contraception during the study period.\n\nExclusion Criteria:\n\n1. Patients with prostatic histopathology exhibiting neuroendocrine, small cell, or sarcomatoid features.\n2. The researchers assessed the primary lesion as unresectable.\n3. Patients who had previously received androgen deprivation therapy (including medical or surgical castration) for more than 3 months, or had undergone focal therapy for prostate cancer, or had received radiotherapy or chemotherapy for prostate cancer.\n4. Patients with severe or uncontrolled underlying diseases who could not tolerate surgery or radiotherapy.\n5. Patients with New York Heart Association (NYHA) Class III\u002FIV congestive heart failure, unstable angina, or a history of myocardial infarction within the past 6 months.\n6. Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent pulmonary disease, chronic liver disease, or HIV infection.\n7. Within the past 5 years, having had other malignant tumors except for prostate cancer, with the exception of cured basal or squamous cell skin cancer.\n8. Suffering from mental illness, mental disability, or being incapable of providing informed consent.","80 Years",{"count":343,"type":20},144,[23],"This multi-center randomized controlled phase II trial was carried out in several hospitals in China to evaluate the efficacy and safety of radiotherapy or radical prostatectomy combined with intense androgen deprivation therapy for newly diagnosed metastatic prostate cancer.",[26],[348,63,349],"metastatic prostate cancer","prostatectomy","2025-05-19",{"date":352,"type":32},"2025-05-28",{"date":354,"type":32},"2024-08-01",{"date":356,"type":20},"2028-07-31",{"name":358,"class":39},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":341,"enrollmentInfo":366,"targetDuration":4,"studyType":21,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":40},"100572859","phase-2-study-of-hrs-2189-combined-hrs-5041-in-prostate-cancer-100572859","NCT06738745","Study of HRS-2189 Combined HRS-5041 in Prostate Cancer","A Phase II Study of HRS-2189 Combined HRS-5041 in Metastatic Prostate Cancer","Inclusion Criteria:\n\n* 18 years to 80 years old (including boundary values), male subjects;\n* ECOG PS Score: 0\\~1;\n* Histologically or cytologically confirmed prostate adenocarcinoma, and no prior diagnosed as neuroendocrine carcinoma or small cell carcinoma;\n* Disease progression when enrolled in the study;\n* Confirmed metastatic disease by CT\u002FMRI\u002F99mTc radioactive bone scan;\n* Subjects must have a life expectancy ≥ 3 months;\n* Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);\n* Male subjects who have partner of childbearing potential should agree to take action of contraception and avoid to donate sperm;\n* Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.\n\nExclusion Criteria:\n\n* Known existence of CNS metastasis or meningeal metastasis, or known history of primary CNS tumor;\n* Severe bone injury caused by bone metastasis identified by investigators, including uncontrolled severe bone pain, pathological bone fracture at the important part and spinal cord compression having occurred for the last 6 months or expected to occur in the near future;\n* Existence of third space fluid that is not well controlled by effective methods, e.g. drainage;\n* Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy, immunological therapy or attenuated live vaccine within 4 weeks before first dose of study therapy (6-week washout period for bicalutamide);\n* Has been enrolled in other clinical trials within 4 weeks before first dose of study therapy;\n* Use of other antitumor treatment during the study;\n* Damage caused by any prior anti-tumor treatment has not recovered to ≤ grade 1 or criteria specified by this study (per NCI-CTCAE 5.0; except alopecia or other tolerable adverse events identified by investigators);\n* Uncontrolled hypertension, or prior hypertensive crisis or history of hypertension;\n* Existence of arterial\u002Fvenous thrombotic event within 6 months before first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral haemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;\n* Existence of one of multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and bowel obstruction), or active gastrointestinal disease or other diseases which may obviously affect distribution of drug absorption, metabolism or excretion;\n* Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU\u002FmL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis;\n* Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia \\>38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator);\n* Subjects with innate or acquired immunodeficiency (such as HIV infection); Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation;\n* Other malignancy within prior 3 years before first dose of study therapy, except curatively treated cancer, including radical therapy-treated skin basal cell carcinoma or skin squamous cell carcinoma, papillary thyroid carcinoma, or any type of in situ carcinoma with complete excision, such as in situ cancer of the cervix, ductal carcinoma in situ of breast;\n* Hypersensitivity to study therapy or any of its excipients;\n* Uncontrolled cardiovascular clinical symptom or disease within 6 months before first dose of study therapy;\n* Other conditions that might influence the study and analysis of results in the opinion of the investigator.",{"count":367,"type":20},90,[23],"Our study is aimed to evaluate the efficacy and safety of HRS-2189 combined with HRS-5041 in metastatic prostate cancer.",[26],"2024-12-13",{"date":373,"type":32},"2024-12-18",{"date":375,"type":20},"2024-12-31",{"date":377,"type":20},"2027-08-31",{"name":379,"class":39},"Fudan University"]