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

Inclusion Criteria:

1. Voluntary participation with signed informed consent and understanding of study procedures.
2. Age ≥18 years.
3. Histologically or cytologically confirmed prostatic adenocarcinoma without neuroendocrine differentiation, small cell, sarcomatoid, spindle cell, or signet ring cell histology.
4. 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.
5. Planned or ongoing androgen deprivation therapy (ADT) with LHRH agonist/antagonist (medical castration) or prior bilateral orchiectomy (surgical castration) within ≤4 weeks before enrollment.
6. 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%
7. 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.
8. Ability to comply with the study protocol as judged by the investigator.
9. Ability to adhere to scheduled visits, treatment plans, and laboratory assessments.

Exclusion Criteria:

1. 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.
2. Prior radiotherapy to prostate cancer metastases.
3. Known visceral metastases (liver, lung, brain, peritoneum, etc.) or diffuse bone marrow metastases.
4. 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.
5. Other prior or concurrent malignancies, unless basal cell carcinoma of the skin or other cancers cured for \>5 years.
6. 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.
7. 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).
8. Severe hepatic or renal dysfunction or other laboratory abnormalities not meeting the organ function requirements specified in Inclusion Criterion #6.
9. Known hypersensitivity or history of severe adverse reactions to study medications (novel hormonal agents), anesthetics, or contrast agents used in the study.
10. 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.
11. Concurrent participation in another interventional clinical study, or use of any investigational drug or medical device within 4 weeks prior to randomization.
12. Any other condition that the investigator considers unsuitable for study participation.

    \-