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

529 Citations (Scopus)

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

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Radiation Oncology
Androgens
Prostate
Radiotherapy
Disease-Free Survival
Adjuvant Radiotherapy
Therapeutics
Prostate-Specific Antigen
Lymph Nodes

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression : Radiation Therapy Oncology Group 9413. / Roach, Mack; DeSilvio, M.; Lawton, C.; Uhl, V.; Machtay, M.; Seider, M. J.; Rotman, M.; Jones, C.; Asbell, S. O.; Valicenti, Richard K; Han, S.; Thomas, C. R.; Shipley, W. S.

In: Journal of Clinical Oncology, Vol. 21, No. 10, 15.05.2003, p. 1904-1911.

Research output: Contribution to journalArticle

Roach, M, DeSilvio, M, Lawton, C, Uhl, V, Machtay, M, Seider, MJ, Rotman, M, Jones, C, Asbell, SO, Valicenti, RK, Han, S, Thomas, CR & Shipley, WS 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, vol. 21, no. 10, pp. 1904-1911. https://doi.org/10.1200/JCO.2003.05.004
Roach, Mack ; DeSilvio, M. ; Lawton, C. ; Uhl, V. ; Machtay, M. ; Seider, M. J. ; Rotman, M. ; Jones, C. ; Asbell, S. O. ; Valicenti, Richard K ; Han, S. ; Thomas, C. R. ; Shipley, W. S. / Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression : Radiation Therapy Oncology Group 9413. In: Journal of Clinical Oncology. 2003 ; Vol. 21, No. 10. pp. 1904-1911.
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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{\%}.",
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T1 - Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression

T2 - Radiation Therapy Oncology Group 9413

AU - Roach, Mack

AU - DeSilvio, M.

AU - Lawton, C.

AU - Uhl, V.

AU - Machtay, M.

AU - Seider, M. J.

AU - Rotman, M.

AU - Jones, C.

AU - Asbell, S. O.

AU - Valicenti, Richard K

AU - Han, S.

AU - Thomas, C. R.

AU - Shipley, W. S.

PY - 2003/5/15

Y1 - 2003/5/15

N2 - 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%.

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