Phase 3 Trial of Dose-Escalated Radiation Therapy and Standard Androgen Deprivation Therapy Versus Dose-Escalated Radiation Therapy and Enhanced Androgen Deprivation Therapy With Orteronel for Men With High-Risk Prostate Cancer (NRG/RTOG 1115).

ABSTRACT:

Purpose

NRG/RTOG 1115 was a phase 3 trial evaluating the addition of orteronel, a CYP17A1 inhibitor, to radiation therapy (RT) plus androgen deprivation therapy (ADT) in men with high-risk prostate cancer.

Methods and materials

The study was designed to evaluate overall survival for 900 men with high-risk prostate cancer (Gleason 9-10, prostate specific antigen (PSA) > 20, or clinical stage T2 or higher with Gleason ≥ 8). Patients were randomized 1:1 to standard of care (SOC) therapy (RT plus 2 years of ADT) or SOC plus 2 years of orteronel. RT entailed image guided conventionally fractionated dose-escalated external beam RT to the prostate and pelvis to 45 Gy using intensity modulated RT with either intensity modulated RT (to 79.2 Gy) or brachytherapy boost. Health-related

SUBMITTER: Hamstra DA 

PROVIDER: S-EPMC12833922 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature