Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed prostate adenocarcinoma, with distant metastasis diagnosed by novel imaging modalities (PSMA PET/CT or PSMA PET/MR), involving ≤10 metastatic sites (amenable to local therapy) and without visceral metastasis. 2. The primary lesion is deemed resectable, or can achieve a resectable state following IADT. 3. Non-castration range (≥50 ng/dl), or the duration of testosterone levels in the castration range is no more than 3 months. 4. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1. 5. Patients must have adequate hematologic function, hepatic function and renal function. 6. 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. 7. Fertile patients must be willing to u