OncoMatch/Clinical Trials/NCT07711314
Adjuvant Rezvilutamide Monotherapy for High-Risk Prostate Cancer After Radical Prostatectomy
Is NCT07711314 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Rezvilutamide Tablets for prostate cancer (post prostatectomy).
Treatment: Rezvilutamide Tablets — Prostate cancer patients with high-risk features who undergo radical prostatectomy (RP) are at a significant risk of biochemical recurrence (BCR) and disease progression. While adjuvant androgen deprivation therapy (ADT) with or without radiotherapy is the current standard of care, long-term ADT is associated with substantial adverse effects, including metabolic syndrome, cardiovascular disease, and bone density loss, which negatively impact patients' quality of life. There is an unmet clinical need to optimize adjuvant treatment strategies to improve survival outcomes while minimizing treatment-related toxicity for this high-risk population. Rezvilutamide is a novel, potent, second-generation oral androgen receptor (AR) inhibitor. This prospective, multicenter, single-arm clinical trial aims to evaluate the efficacy and safety of rezvilutamide monotherapy as an adjuvant treatment in patients with localized prostate cancer who have a high risk of recurrence following radical prostatectomy. The study plans to enroll 48 male patients (aged 18-75 years) who have completed radical prostatectomy within 12 weeks, have achieved a postoperative prostate-specific antigen (PSA) level of \< 0.1 ng/mL within 8 weeks, and possess a high recurrence risk defined by a CAPRA-S score of ≥ 6. Eligible patients will receive rezvilutamide monotherapy at a dose of 240 mg orally once daily for 12 cycles (28 days per cycle, totaling 48 weeks). The primary endpoint of the study is the 2-year biochemical progression-free survival (bPFS) rate. Secondary endpoints include event-free survival rate, 5-year bPFS, 5-year metastasis-free survival (MFS), testosterone recovery rate and time at 2 years, overall safety, and health-related quality of life assessed by the FACT-P and EPIC-26 questionnaires. By exploring this monotherapy approach, the study hopes to provide a new, effective, and better-tolerated adjuvant treatment option that can improve the prognosis of high-risk patients post-prostatectomy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Required: Stage LOCALIZED
Excluded: Stage CN1, CM1
Localized prostate cancer (assessed by conventional imaging such as CT and bone scan), having undergone radical prostatectomy within 12 weeks prior to enrollment. Preoperative conventional imaging (e.g., CT or bone scan) indicating pelvic lymph node metastasis (cN1) or distant metastasis (cM1) [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: androgen deprivation therapy
Prior androgen deprivation therapy (ADT) (including medical or surgical castration)
Cannot have received: focal therapy for prostate cancer
focal therapy for prostate cancer
Cannot have received: chemotherapy for prostate cancer
chemotherapy for prostate cancer
Cannot have received: radiotherapy for prostate cancer
radiotherapy for prostate cancer
Cannot have received: second-generation antiandrogen (abiraterone, apalutamide, enzalutamide, darolutamide)
Prior treatment with second-generation anti-androgens (e.g., abiraterone, apalutamide, enzalutamide, darolutamide, etc.)
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L (without blood transfusion or G-CSF within 14 days); HGB ≥ 90 g/L; PLT ≥ 100 × 10^9/L; INR or PT ≤ 1.5 × ULN (without blood product transfusion within 14 days)
Kidney function
Creatinine clearance rate ≥ 30 mL/min
Liver function
Total bilirubin (TBIL) ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN
Cardiac function
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)
Must meet the following laboratory criteria: (1) ANC ≥ 1.5 × 10^9/L (without blood transfusion or G-CSF within 14 days). (2) HGB ≥ 90 g/L. Platelet count (PLT) ≥ 100 × 10^9/L. (3) INR or PT ≤ 1.5 × ULN (without blood product transfusion within 14 days). (4) Creatinine clearance rate ≥ 30 mL/min. (5) Total bilirubin (TBIL) ≤ 1.5 × ULN. (6) AST and ALT ≤ 2.5 × ULN. 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) [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07711314 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior androgen deprivation therapy, focal therapy for prostate cancer, chemotherapy for prostate cancer disqualifies patients from enrollment.
What disease stage is eligible?
Stage LOCALIZED is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages