Study on Triple Therapy Combined With HIFU for High-Tumor-Burden mHSPC

Prostate cancer ranked as the second most commonly diagnosed cancer and the fifth leading cause of cancer death among men worldwide in 2020, with approximately 1.4 million new cases and 375,000 deaths. In China, both the incidence and mortality rates of prostate cancer have shown a significant upward trend. For prostate cancer treatment, effective management of high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC) is crucial for delaying disease progression and improving long-term survival, representing one of the most critical clinical challenges. Although androgen deprivation therapy (ADT) combined with docetaxel or novel hormonal therapy has been established as standard treatment in both domestic and international guidelines, the clinical adoption of these novel ADT-based combination regimens remains limited due to the risk of adverse events (AEs) associated with chemotherapy and prolonged hormone exposure. Recent advances in mHSPC treatment have brought new hope. The phase III PEACE-1 trial demonstrated that adding abiraterone to standard ADT plus docetaxel significantly reduced mortality risk (median overall survival not reached vs. 4.4 years; HR, 0.75; 95% CI, 0.59-0.96; P=0.021). SonaCare Medical's Sonablate HIFU system is a global leader in high-intensity focused ultrasound technology, being the first prostate tissue ablation device to receive FDA 510(k) clearance. On July 8, 2020, the Sonablate device obtained approval from China's National Medical Products Administration (NMPA Approval No. 20203010342) for treating both prostate cancer and benign prostatic hyperplasia. Therefore, this project proposes a single-arm clinical study. From 2022 to 2025, eligible high-tumor-burden mHSPC patients will be enrolled after providing informed consent and baseline data collection. Participants will receive either: * Apalutamide + docetaxel + ADT, or * Apalutamide + ADT combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy The primary endpoint is 3-year radiographic progression-free survival (rPFS) rate. Follow-up assessments will be conducted per protocol to evaluate efficacy and safety outcomes. This study aims to provide new therapeutic possibilities for high-tumor-burden mHSPC through combination therapy, potentially improving patient prognosis and reducing disease burden.