Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413

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

Research output: Contribution to journalArticle

539 Scopus citations

Abstract

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%.

Original languageEnglish (US)
Pages (from-to)1904-1911
Number of pages8
JournalJournal of Clinical Oncology
Volume21
Issue number10
DOIs
StatePublished - May 15 2003
Externally publishedYes

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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    Roach, M., DeSilvio, M., Lawton, C., Uhl, V., Machtay, M., Seider, M. J., Rotman, M., Jones, C., Asbell, S. O., Valicenti, R. K., Han, S., Thomas, C. R., & Shipley, W. S. (2003). Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. Journal of Clinical Oncology, 21(10), 1904-1911. https://doi.org/10.1200/JCO.2003.05.004