Phase I II T rial C omparing W hole-Pelvic V ersus P rostate-Only Radiotherapy a nd N eoadjuvant V ersus A djuvant C ombined Androgen S uppression: R adiation T herapy O ncology Group 9 413

Purpose: This trial tested the hypothesis that combined androgen suppression (CAS) and whole-pelvic (WP) radiotherapy (RT) followed by a boost to the prostate improves progression-free survival (PFS) by 10% compared with CAS and prostate-only (PO) RT. This trial also tested the hypothesis that neoadjuvant and concurrent hormonal therapy (NCHT) improves PFS compared with adjuvant hormonal therapy (AHT) by 10%. Materials and Methods: Eligibility included localized prostate cancer with an elevated prostate-specific antigen (PSA) < 100 ng/mL and an estimated risk of lymph node (LN) involvement of 15%. Between April 1, 1995, and June 1, 1999, 1,323 patients were accrued. Patients were randomly assigned to WP NCHT, PO NCHT, WP AHT, or PO AHT. Failure for PFS was defined as the first occurrence of local, regional, or distant disease; PSA failure; or death for any cause. Results: With a median follow-up of 59.5 months, WP RT was associated with a 4-year PFS of 54% compared with 47% in patients treated with PO RT (P .022). Patients treated with NCHT experienced a 4-year PFS of 52% versus 49% for AHT (P .56). When comparing all four arms, there was a progression-free difference among WP RT NCHT, PO RT NCHT, WP RT AHT, and PO RT AHT (60% v 44% v 49% v 50%, respectively; P .008). No survival advantage has yet been seen. Conclusion: WP RT NCHT improves PFS compared with PO RT and NCHT or PO RT and AHT, and compared with WP RT AHT in patients with a risk of LN involvement of 15%. J Clin Oncol 21:1904-1911. © 2003 by American Society of Clinical Oncology.