Adjuvant Rezvilutamide Monotherapy for High-Risk Prostate Cancer After Radical Prostatectomy (ARMOR)

Inclusion Criteria:

• Age and Diagnosis: Male patients aged ≥ 18 and ≤ 75 years with histologically or cytologically confirmed prostate adenocarcinoma.
• Disease Stage and Surgery: Localized prostate cancer (assessed by conventional imaging such as CT and bone scan), having undergone radical prostatectomy within 12 weeks prior to enrollment.
• Postoperative PSA: Postoperative prostate-specific antigen (PSA) level < 0.1 ng/mL within 8 weeks after surgery.
• Risk Stratification: Postoperative CAPRA-S score ≥ 6, indicating a high risk of recurrence.
• Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

• Adequate Organ Function: Must meet the following laboratory criteria:

  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (without blood transfusion or G-CSF within 14 days).
  2. Hemoglobin (HGB) ≥ 90 g/L. Platelet count (PLT) ≥ 100 × 10^9/L. (3) Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × upper limit of normal (ULN) (without blood product transfusion within 14 days).

  (4)Creatinine clearance rate ≥ 30 mL/min. (5) Total bilirubin (TBIL) ≤ 1.5 × ULN. (6) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.

• Radiotherapy Intention: Patients who are unfit for or refuse to receive radiotherapy.
• Contraception: Patients of reproductive potential must be willing to use highly effective contraceptive methods during the study and for 12 weeks after the last dose of study drug. I
• informed Consent: Capable of understanding and providing written informed consent (ICF) and willing to comply with study requirements and evaluation schedules.

Exclusion Criteria:

• Histology: Prostate tissue pathology showing neuroendocrine, small cell, or sarcomatoid features.
• Metastasis: Preoperative conventional imaging (e.g., CT or bone scan) indicating pelvic lymph node metastasis (cN1) or distant metastasis (cM1).
• Prior Therapies: Prior androgen deprivation therapy (ADT) (including medical or surgical castration), focal therapy for prostate cancer, or chemotherapy/radiotherapy for prostate cancer.
• Prior Novel Hormonal Agents: Prior treatment with second-generation anti-androgens (e.g., abiraterone, apalutamide, enzalutamide, darolutamide, etc.). ·Recent Surgery: Major surgery requiring general anesthesia (other than radical prostatectomy) within 28 days prior to the first dose of study drug.
• Other Malignancies: History of or concurrent other malignancies within the past 2 years, except for cured non-melanoma skin cancer and superficial bladder tumors (Ta, non-invasive; Tis, carcinoma in situ; and T1).
• Thromboembolic Events: Arterial or venous thromboembolic events (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism) within the past 6 months, or currently receiving therapeutic anticoagulation with warfarin or heparin.
• Cardiovascular Conditions: Heart rate-corrected QT interval (QTc) > 500 ms; severe cardiovascular disease (myocardial ischemia or infarction grade ≥ II, uncontrolled arrhythmias, NYHA class III-IV heart failure, or LVEF < 50% on echocardiogram).
• Allergies: Known allergy to any study drug or its excipients.
• Active Infections/Hepatitis: Active viral hepatitis requiring treatment (HBV DNA ≥ 500 IU/mL for HBV carriers; positive HCV RNA for HCV antibody-positive patients); known human immunodeficiency virus (HIV) infection; or any other active infection.
• Autoimmune Diseases: Active autoimmune disease or history of autoimmune disease requiring systemic treatment, known history of allogeneic organ or hematopoietic stem cell transplant, or long-term high-dose use of corticosteroids or other immunomodulators.
• Systemic Diseases: History of interstitial lung disease or uncontrolled systemic diseases (e.g., diabetes, hypertension, acute lung disease).
• Seizures: History of epilepsy or conditions that may induce seizures.
• Substance Abuse/Compliance: Underlying medical conditions, alcohol/drug abuse, or dependence that would interfere with drug administration, results interpretation, or pose a high risk for complications.
• Sperm Donation/Family Planning: Men engaging in sexual activity with women of childbearing potential unwilling to use a condom with spermicide, unwilling to abstain from sperm donation during the study and for at least 3 months after the last dose, or planning to have children during this period.
• Concurrent Trials: Concurrent participation in another therapeutic clinical study