Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer

Main Inclusion Criteria:

• Age ≥ 40 years, male.
• Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
• pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
• Patients with PSA < 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
• Biochemical recurrence (two consecutive rises in PSA with absolute values > 0.2ng/ml, the time interval ≥ 2 weeks apart ) and no local recurrence or distant metastatic lesions on conventional imaging (bone scan and CT/MRI scan);
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
• Estimated life expectancy >10 year;
• Adequate laboratory parameters

• Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L
• Platelet count (PLT) ≥ 100 x 10^9/L
• Haemoglobin (Hb) ≥ 90 g/L
• Serum creatinine (Cr) ≤ 1.5 x upper limit of normal(ULN) or creatinine clearance > 50 ml/min.
• Total bilirubin (TBIL) ≤ 1.5 x ULN.
• Glutamic oxaloacetic transaminase (AST/SGOT) or glutamic alanine transaminase (ALT/SGPT) levels ≤ 2.5 x ULN.
• International normalised ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5 x ULN .
• Left ventricular ejection fraction (LVEF) ≥ 50%.
• Patients able to comply with the protocol. Arm 1 subjects are proposed to receive salvage radiation therapy, while arm 2 subjects are not suitable for or refuse radiation therapy.
• Signed informed consent.

Main Exclusion Criteria:

• Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
• Postoperative biochemical recurrence with PSA > 2 ng/ml.
• Postoperative pathology containing neuro-endocrine differentiation or small cell features.
• Prior malignancy other than prostate cancer in the past three years.
• History of any of the following:

• Seizure or known condition that may pre-dispose to seizure
• Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to entry.
• Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)
• Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.