A Multi-center, Randomized, Open-label Clinical Trial Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in High Tumor Burden mHSPC
Objective: To explore whether a 6-month course of Rezvilutamide in the triple therapy regimen is non-inferior to long-term Rezvilutamide treatment in improving radiographic progression-free survival (rPFS) in patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC). Secondary
Objectives: To evaluate and compare the time to prostate-specific antigen (PSA) progression, time to next bone-related event, time to initiation of subsequent anti-prostate cancer treatment, and objective response rate (ORR) between the 6-month and long-term course of Rezvilutamide with androgen deprivation therapy (ADT) plus docetaxel in patients with high tumor burden mHSPC. To assess and compare the incidence of adverse events between the 6-month and long-term course of Rezvilutamide with ADT plus docetaxel in patients with high tumor burden mHSPC. Exploratory Objectives: To observe the circulating tumor cell status at 6 months, 12 months, 18 months, and 24 months in patients with high tumor burden mHSPC receiving the triple therapy regimen.
⁃ Age ≥ 18 years, male.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine or small cell features.
• High tumor burden, defined as having at least one of the following conditions: 1) Bone scan showing ≥4 bone metastatic lesions (with at least one site outside the pelvis or spine). 2) CT/MRI revealing visceral metastatic lesions (excluding lymph nodes).
• Planned to receive or maintain androgen deprivation therapy (ADT) during the study period, either by continuous LHRHa treatment or previous bilateral orchiectomy (surgical castration), concurrently with 6 cycles of docetaxel chemotherapy.
• Organ function levels must meet the following requirements:
∙ Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L.
‣ Platelets (PLT) ≥ 100 × 10\^9/L.
‣ Hemoglobin (Hb) ≥ 90 g/L.
‣ Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN).
‣ Alanine aminotransferase (ALT) ≤ 2.5 × ULN.
‣ Aspartate aminotransferase (AST) ≤ 2.5 × ULN.
‣ Blood urea nitrogen (BUN) (or urea) and creatinine (Cr) ≤ 1.5 × ULN.
‣ Left ventricular ejection fraction (LVEF) ≥ 50%.
• Judged by the investigator to be able to comply with the trial protocol.
• Voluntarily participate in the clinical trial, understand the study procedures, and have signed the informed consent form.