Ten-Year Outcomes of a Phase 3, Multicenter, Randomized Controlled Trial (SHIP0804) With 3-Month Neoadjuvant Androgen Deprivation Prior to ¹²⁵I-Seed Transperineal Prostate Brachytherapy Followed by Nil Versus 9-Month Adjuvant Hormonal Therapy in Patients With Intermediate-Risk Prostate Cancer.

Abstract

To analyze the effects of adjuvant hormonal therapy (AHT) on time to event after neoadjuvant androgen deprivation therapy (ADT) and ¹²⁵I-transperineal prostate brachytherapy (TPPB), compared with neoadjuvant ADT and TPPB only, in patients with intermediate-risk prostate cancer (IRPC). In this multicenter, open-label, phase 3 randomized controlled trial (SHIP0804), 421 patients with IRPC were randomly assigned to either 9-month AHT (AHT arm) or no AHT (non-AHT arm) after 3 months of neoadjuvant ADT and TPPB. The primary endpoint was biochemical progression-free survival, and secondary endpoints included overall survival and clinical progression-free survival. Prostatic biopsy results 36 months after treatment were evaluated in a correlative investigation (SHIP36B). With a median follow-up of over 11 years, the 10-year biochemical progression-free survival rates were comparable: 82.9% in the AHT group and 78.4% in the non-AHT group (P = .51). Results were consistent across key prognostic indicators such as age at randomization, baseline prostate-specific antigen level, clinical stage, Gleason grade group, number of National Comprehensive Cancer Network intermediate-risk factors, and prostatic volume. The secondary endpoints, including overall survival and clinical progression-free survival, were also comparable between the 2 arms. Grade 3 or higher adverse events occurred in 5.4% and 1.4% of patients in the AHT and non-AHT arms, respectively. At 36-month post-TPPB prostate biopsy, only 3.1% of biopsied patients tested positive for residual tumors. There were no deaths due to prostate cancer in either group. Adding 9-month AHT to TPPB after 3-month neoadjuvant ADT did not improve long-term outcomes in patients with IRPC. These findings suggest that moderate-term AHT may not offer substantial benefits and thus should not be considered a standard treatment in this population with IRPC.