Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer
Trial Parameters
Brief Summary
This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.
Eligibility Criteria
Inclusion Criteria: 1. All patients must have been histologically diagnosed of prostate cancer and must be eligible for radical prostatectomy. 2. All patients must undergo thorough tumor staging and meet one of the following criteria: a) multi-parameter MRI or PSMA PET/CT shows clinical staging of primary tumor ≥ T3; b) Gleason score of primary tumor ≥ 8; c)prostate specific antigen(PSA) ≥20 ng/ml; d) Imaging evaluation shows regional lymph node metastases (N1). 3. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1. 4. Patients must have adequate hematologic function, hepatic function, renal function and cardiac function. 5. 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 bewilling to obey the prohibitions and restrictions specified in the research protocol. 6. Fertile patients must be willing to use highly