Rezvilutamide With Radical Prostatectomy and Metastasis-Directed Therapy in Oligometastatic Prostate Cancer

Inclusion criteria

• Voluntary participation with signed informed consent and understanding of study procedures.
• Age ≥18 years.
• Histologically or cytologically confirmed prostatic adenocarcinoma without neuroendocrine differentiation, small cell, sarcomatoid, spindle cell, or signet ring cell histology.
• Metastatic hormone-sensitive prostate cancer (mHSPC) with oligometastatic disease defined as: a) ≤10 metastatic lesions combined (bone lesions on Tc-99m bone scan plus extra-pelvic lymph nodes on CT/MRI); and b) No visceral metastases on CT/MRI.
• Planned or ongoing androgen deprivation therapy (ADT) with LHRH agonist/antagonist (medical castration) or prior bilateral orchiectomy (surgical castration) within ≤4 weeks before enrollment.
• Adequate organ function (without transfusion or hematopoietic growth factor support within 2 weeks prior to screening labs):

• Absolute neutrophil count (ANC) ≥1.5×10⁹/L
• Platelet count (PLT) ≥100×10⁹/L
• Hemoglobin (Hb) ≥90 g/L
• Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance >50 mL/min
• Total bilirubin (BIL) ≤1.5×ULN
• AST/SGOT or ALT/SGPT ≤2.5×ULN
• International normalized ratio (INR) ≤1.5, PT and APTT ≤1.5×ULN
• Left ventricular ejection fraction (LVEF) ≥50%
• Male patients with female partners of childbearing potential must agree to use effective contraception during the study and for 3 months after the last dose, and must not donate sperm during this period.
• Ability to comply with the study protocol as judged by the investigator.
• Ability to adhere to scheduled visits, treatment plans, and laboratory assessments.

Exclusion criteria

• Prior radical prostatectomy, pelvic radiotherapy, prostatic ablation, or any systemic anti-prostate cancer therapy (including novel hormonal therapy, chemotherapy, radionuclide therapy, cancer vaccines, or immune checkpoint inhibitors), except ADT initiated ≤4 weeks prior to randomization that meets inclusion criteria.
• Prior radiotherapy to prostate cancer metastases.
• Known visceral metastases (liver, lung, brain, peritoneum, etc.) or diffuse bone marrow metastases.
• Severe contraindications to surgery or radiotherapy, including major cardiovascular disease (e.g., NYHA Class III-IV heart failure, recent myocardial infarction), pulmonary insufficiency unable to tolerate anesthesia, severe bleeding tendency, or bone marrow suppression.
• Other prior or concurrent malignancies, unless basal cell carcinoma of the skin or other cancers cured for >5 years.
• Active infections, including active hepatitis B (HBV DNA >2×10³ IU/mL), hepatitis C RNA positive with hepatic impairment, HIV infection, or inadequately treated syphilis.
• Uncontrolled major cardiovascular disease within 6 months prior to screening, including: a) unstable angina or recent myocardial infarction (within 6 months); b) clinically significant arrhythmias (e.g., sustained ventricular tachycardia); c) heart failure (NYHA Class ≥III).
• Severe hepatic or renal dysfunction or other laboratory abnormalities not meeting the organ function requirements specified in Inclusion Criterion #6.
• Known hypersensitivity or history of severe adverse reactions to study medications (novel hormonal agents), anesthetics, or contrast agents used in the study.
• Any medical, psychological, or social factors that may affect patient compliance or interfere with study outcome assessment, including psychiatric disorders, substance abuse, or other conditions deemed unsuitable by the investigator.
• Concurrent participation in another interventional clinical study, or use of any investigational drug or medical device within 4 weeks prior to randomization.
• Any other condition that the investigator considers unsuitable for study participation.

-