Radiotherapy Combined With Fluzopanib and Abiraterone Acetate Tablets (II) Treatment for mCRPC
Trial Parameters
Brief Summary
This study is an open label, single arm, multicenter clinical trial. The aim of this study is to evaluate the efficacy, safety, and quality of life of radiotherapy combined with Fuzuloparib and Abiraterone Acetate Tablets（Ⅱ） as first-line treatment for castration resistant prostate cancer patients. The study aims to enroll 40 eligible subjects with PSA response rate (PSA 50) as the primary endpoint.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old, male 2. ECOG score is 0 or 1 3. Untreated first-line metastatic castration resistant prostate cancer patients 4. Allow the use of a new endocrine drug treatment once during hormone sensitive stages 5. The organ function level must meet the following requirements (no blood transfusion or hematopoietic growth factor therapy received within 2 weeks before blood routine screening): ANC ≥ 1.5 × 109/L PLT≥100×109/L； • Hb≥90 g/L； • TBIL ≤ 1.5 × ULN (excluding subjects with Gilbert syndrome) • ALT and AST ≤ 2.5 × ULN; • Cr≤1.5×ULN； • LVEF≥50%； • QTcF≤450 ms。 6. If the partner is a subject with fertility, they should undergo surgical sterilization or agree to receive it during and at the end of the trial period 7. Sign a written informed consent form and expect good compliance with the research protocol Exclusion Criteria: 1. Previously received any PARPi treatment for prostate cancer (including but not limited to Olaparib, Nilaparib, Terazopanib, Luca