ARES is a multicenter, single-arm, phase 2 trial to evaluate the efficacy and safety of ADT in combination with apalutamide as an adjuvant regimen for patients with high risk of recurrence after radical prostatectomy.
Prostate cancer diagnosed histologically or cytologically in males ≥18 years and ≤75 years of age;
Localized prostate cancer (assessed by conventional imaging tools such as CT and bone scan) within 12 weeks after radical prostatectomy;
PSA < 0.1 ng/ml within 8 weeks after surgery;
Postoperative CAPRA-S score ≥ 6, suggesting a higher risk of recurrence;
Patients with neuroendocrine, small cell, or sarcomatoid features in prostate histopathology;
Pelvic lymph node metastasis (cN1) or distant metastasis (cM1) indicated preoperatively by traditional imaging procedures such as CT or bone scan;
Prior treatment by androgen deprivation therapy (including medication or surgical castration), focal therapy for prostate cancer, or radiotherapy and chemotherapy for prostate cancer;
Prior treatment with second-generation antiandrogen (e.g., abiraterone, apalutamide, enzalutamide, darolutamide, etc.);
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
Xian-Janssen Pharmaceutical Ltd.
Collaborator