TY - JOUR
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, R. 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%.
AB - 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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U2 - 10.1200/JCO.2003.05.004
DO - 10.1200/JCO.2003.05.004
M3 - Article
C2 - 12743142
AN - SCOPUS:0037674063
SN - 0732-183X
VL - 21
SP - 1904
EP - 1911
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 10
ER -