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

Main Inclusion Criteria:

1. Age ≥ 40 years, male.
2. Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
3. pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
4. Patients with PSA < 0.1ng/ml within 8 weeks after radical prostatectomy (RP) andmaintained for at least 6 months;
5. 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 metastaticlesions on conventional imaging (bone scan and CT/MRI scan);
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
7. Estimated life expectancy >10 year;
8. 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 activatedpartial thromboplastin time (APTT)≤1.5 x ULN .
• Left ventricular ejection fraction (LVEF) ≥ 50%.

9. Patients able to comply with the protocol. Arm 1 subjects are proposed to receivesalvage radiation therapy, while arm 2 subjects are not suitable for or refuseradiation therapy.
10. Signed informed consent.

Main Exclusion Criteria:

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

• Seizure or known condition that may pre-dispose to seizure
• Severe or unstable angina, myocardial infarction, symptomatic congestive heartfailure, arterial or venous thromboembolic events (eg, pulmonary embolism,cerebrovascular accident including transient ischemic attacks), or clinicallysignificant ventricular arrhythmias within 6 months prior to entry.
• Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)

6. Any other serious or uncontrolled illness which in the opinion of the investigatormakes it undesirable for the patient to enter the trial.