Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
Trial Parameters
Brief Summary
To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or rezvilutamide in combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).
Eligibility Criteria
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) and maintained 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 metastatic lesions 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 t