Evaluation of Rezvilutamide Oral Monotherapy After Prostate Surgery in Men With High-Risk Prostate Cancer

What this Trial Is About

Researchers are evaluating rezvilutamide, a new oral androgen receptor inhibitor, as a single-agent adjuvant treatment for men with localized prostate cancer who are at high risk of recurrence after radical prostatectomy. This phase 2 clinical trial targets male patients aged 18 to 75 years who have undergone surgery within 12 weeks and achieved a very low postoperative PSA level, with a high recurrence risk defined by a CAPRA-S score of 6 or higher. The study aims to improve survival outcomes while reducing side effects seen with traditional long-term androgen deprivation therapy. Participants will receive rezvilutamide orally at a dose of 240 mg once daily for 12 cycles, each lasting 28 days, totaling 48 weeks of treatment. The medication is taken as three 80 mg tablets daily, with dose adjustments allowed for intolerable side effects. This trial differs from standard care by using rezvilutamide alone without combining it with radiotherapy or other hormone therapies. Treatment starts between 4 and 12 weeks after surgery and continues continuously unless dose modifications are needed. During the study, participants will be monitored regularly with laboratory tests, quality of life questionnaires FACT-P and EPIC-26, and assessments of testosterone recovery. The primary outcome is the 2-year biochemical progression-free survival rate, measuring time without signs of cancer recurrence. Secondary outcomes include event-free survival, 5-year progression-free and metastasis-free survival, overall safety, and patient-reported quality of life. Participants will be followed for up to 5 years to evaluate longer-term outcomes and safety, with study completion planned for May 2030.

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