[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642088":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":41,"locations":46,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":27,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":93,"whyStopped":27,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"PSMA PET\u002FCT-Guided SBRT + Darolutamide + ADT","EXPERIMENTAL","After a 6-month run-in period of darolutamide plus androgen deprivation therapy, eligible participants without disease progression and with residual PSMA PET\u002FCT-positive active tumor lesions will receive PSMA PET\u002FCT-guided stereotactic body radiotherapy to all active tumor lesions while continuing darolutamide plus androgen deprivation therapy.",[13,14,15],"Radiation: Stereotactic Body Radiotherapy (SBRT)","Drug: Darolutamide 600 mg twice daily","Drug: Androgen Deprivation Therapy (ADT)",{"label":17,"type":18,"description":19,"interventionNames":20},"Darolutamide + ADT","ACTIVE_COMPARATOR","After a 6-month run-in period of darolutamide plus androgen deprivation therapy, eligible participants without disease progression and with residual PSMA PET\u002FCT-positive active tumor lesions will continue darolutamide plus androgen deprivation therapy without local radiotherapy.",[14,15],[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","Stereotactic Body Radiotherapy (SBRT)","Stereotactic body radiotherapy will be delivered in the experimental arm after the 6-month run-in period of darolutamide plus androgen deprivation therapy. Radiotherapy will target all residual PSMA PET\u002FCT-positive active tumor lesions, while participants continue darolutamide plus androgen deprivation therapy. Target lesions may include active lesions in the prostate or prostate bed and metastatic sites. Dose and fractionation will be selected according to lesion location, lesion size, and organ-at-risk constraints as specified in the study protocol.",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"DRUG","Darolutamide 600 mg twice daily","Darolutamide will be administered orally at 600 mg twice daily with food during the 6-month run-in period in combination with androgen deprivation therapy. After randomization, darolutamide will be continued in both treatment groups according to the assigned treatment strategy. Treatment may be interrupted or dose-reduced according to protocol-defined toxicity management rules.",[17,9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Androgen Deprivation Therapy (ADT)","Androgen deprivation therapy will be maintained throughout study treatment in both groups. The method of androgen deprivation therapy will be selected by the investigator according to the participant's clinical condition and may include surgical castration or medical castration with a luteinizing hormone-releasing hormone agonist or antagonist. Treatment will aim to maintain castrate testosterone levels according to the study protocol.",[17,9],[38],{"name":39,"affiliation":5,"role":40},"Hao Zeng, MD, PhD","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":27,"email":45},"CONTACT","86 28 85422026","kucaizeng@163.com",[47],{"facility":48,"status":27,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":27},"West China Hospital, Sichuan University","Chengdu","Sichuan","610041","China","CN",{"type":55,"coordinates":56},"Point",[57,58],104.06667,30.66667,{"lat":58,"lon":57},{"type":40,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Hao Zeng","Professor, Department of Urology",[64],{"name":65,"class":66},"Bayer","INDUSTRY","100642088","phase-2-psma-petct-guided-sbrt-plus-darolutamide-in-mhspc-100642088",false,"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.","MALE","18 Years","85 Years",{"count":79,"type":80},254,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","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.",[86],"Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)",[88,89,90,91,92],"PSMA PET\u002FCT","SBRT","Darolutamide","Androgen Deprivation Therapy","Metastasis-Directed Therapy","NOT_YET_RECRUITING","2026-06-14",{"date":96,"type":97},"2026-06-16","ACTUAL",{"date":99,"type":80},"2026-08-01",{"date":101,"type":80},"2031-10-01",{"name":5,"class":6},1]