NEoAdjuvant Radiohormonal Therapy Versus Standard of Care for Oligometastatic Prostate Cancer (NEAR-TOP): Study protocol of a multicenter, open-label, randomised controlled trial

Background: Metastatic prostate cancer is commonly treated with androgen deprivation therapy (ADT) and chemotherapy, which often leads to treatment resistance and disease progression with limited effective interventions. Recent advances in robotic surgery and precision radiotherapy have prompted research into comprehensive treatments for low-burden metastatic prostate cancer, particularly oligometastatic prostate cancer (OMPC). Our phase I/II clinical study confirmed the safety and efficacy of neoadjuvant radiotherapy combined with endocrine therapy before radical prostatectomy, warranting further investigation. Methods: This study protocol outlines a prospective, open-label, multicenter, randomized controlled trial to evaluate preoperative neoadjuvant radiohormonal therapy versus standard care in OMPC. The experimental group receives LHRHa, abiraterone, IMRT for pelvic lesions, and SBRT for extrapelvic lesions, followed by RARP and lymph node dissection. The control group receives long-term LHRHa and abiraterone. The primary endpoint is 3-year failure-free survival (FFS), and secondary endpoints include time to CRPC, 2-year FFS, OS, TRG rating, and complications. Conclusion: This trial is the first to assess whether neoadjuvant radiohormonal therapy with robotic prostatectomy offers better prognostic outcomes than long-term endocrine therapy alone for OMPC. The results aim to provide high-level evidence for this approach, potentially influencing future treatment protocols. Trial registration: The study has been registered on clinicaltrials.gov (NCT05707468).