Radical prostatectomy (RP) is the standard surgical treatment for localized prostate cancer (LPC). However, approximately 40% of patients experience biochemical recurrence within 10 years after RP. Patients with high risk of recurrence, as determined by the Cancer of the Prostate Risk Assessment-Surgery (CAPRA-S) score, have a 5-year biochemical progression-free survival (bPFS) rate of 29.3%, significantly lower than the 91.4% seen in patients with low risk. There is a need for effective strategies to prevent biochemical recurrence in high-risk patients. This study aims to explore the potential benefit of intensifying adjuvant treatment based on post-RP features. The study will evaluate the efficacy and safety of a novel adjuvant regimen combining apalutamide 240 mg and androgen deprivation therapy (ADT) in patients with high risk of recurrence after RP.

The ARES study is a multicenter, single-arm, phase 2 trial. Eligible patients have localized prostate cancer and undergo RP within 12 weeks of enrollment, with a CAPRA-S score of ≥6. Patients with a history of ADT or radiotherapy are excluded. A total of 103 patients will be recruited from three hospitals in China. The study treatment consists of oral apalutamide 240 mg plus ADT. Treatment initiation occurs within 12 weeks after RP, with apalutamide administered for 12 cycles (48 weeks) on a 28-day cycle. The primary endpoint is the 2-year bPFS rate. Secondary endpoints include event-free survival, 5-year bPFS rate, 5-year metastasis-free survival, quality of life assessment (Functional Assessment of Cancer Therapy-Prostate), 2-year testosterone recovery rate, and time to testosterone recovery. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The study has received approval from the Ethics Committee of Nanjing Drum Hospital.

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This multicenter, single-arm, phase 2 trial aims to evaluate the efficacy and safety of combining ADT with apalutamide as an adjuvant regimen in patients with high risk of recurrence after RP. The results of this study will contribute to our understanding of the potential benefits of this treatment approach for reducing recurrence and improving outcomes in this patient population. Clinical trial information:NCT05778097.