Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.
Males aged ≥40 years and ≤80 years.
Histologically or cytologically confirmed prostate adenocarcinoma.
Metastatic disease.
Eligible for ADT and Docetaxel.
Prior use of LHRH agonists/antagonists; second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), or other investigational AR inhibitors; CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.
Received radiation therapy/radiopharmaceutical treatment within 2 weeks before randomization.
Any of the following conditions within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV).
Previous malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or superficial bladder cancer not invading the deeper muscle layer (i.e., pTis, pTa, and pT1) and any other cancer in complete remission for at least 5 years before randomization.
Parallel
Docetaxel
DrugThis is Triple drug regimen for mHSPC
Rezvilutamide
DrugThis is doubling drug regimen for mHSPC
rPFS
radiographic Progression-Free Survival
prostate-specific antigen (PSA) response rate
percentage of patients with a decreasing PSA following the regimens discussed above
time to castration-resistant prostate cancer (CRPC)
time to PSA progression
time to next bone-related event
Including bone structure, pain, etc.
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