RTOG 9408 — Radiotherapy and Short-Term Androgen Deprivation for Localized Prostate Cancer

Phase 3 · 2011 · Prostate Cancer

Design

Randomized phase 3 trial comparing external-beam radiotherapy alone versus radiotherapy preceded by and combined with 4 months of short-term androgen deprivation therapy (goserelin plus flutamide) in men with localized prostate cancer.

Population

1,979 men with clinical stage T1b-T2b prostate cancer and PSA of 20 ng/mL or less, predominantly intermediate-risk disease.

Primary Endpoint

Overall survival

Key Result

Adding short-term ADT improved 10-year overall survival from 57% to 62% (HR for death 1.17 favoring combined therapy; disease-specific mortality reduced from 8% to 4%), with benefit concentrated in intermediate-risk patients.

Guideline Impact

Standard of care for intermediate-risk prostate cancer (NCCN, ASTRO/ASCO/AUA guidelines)