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Phase III Trial Comparing Whole-Pelvic Versus Prostate-Only Radiotherapy and Neoadjuvant Versus Adjuvant Combined Androgen Suppression: Radiation Therapy Oncology Group 9413

M. Roach, III, M. DeSilvio, C. Lawton, V. Uhl, M. Machtay, M.J. Seider, M. Rotman, C. Jones, S.O. Asbell, R.K. Valicenti, S. Han, C.R. Thomas, Jr, W.S. Shipley

From the University of California at San Francisco, San Francisco, and Radiology Associates of Sacramento, Sacramento, CA; Radiation Therapy Oncology Group Statistical Headquarters, University of Pennsylvania, Albert Einstein Medical Center, and Thomas Jefferson University, Philadelphia, PA; Medical College of Wisconsin, Milwaukee, WI; Akron City Hospital, Akron, OH; State University of New York Health Science Center at Brooklyn, Brooklyn, NY; Wayne State University, Detroit, MI; University of Texas Health Science Center at San Antonio, San Antonio, TX; and Massachusetts General Hospital, Boston, MA.

Address reprint requests to Mack Roach III, MD, University of California San Francisco, 1600 Divisadero St, Suite H1031, San Francisco, CA 94143-1708; email: roach{at}radonc17.ucsf.edu.

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%.

Supported by grants RTOG U10 CA21661, CCOP U10 CA37422, and Stat U10 CA32115 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD.

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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