International Journal of Radiation Oncology*Biology*Physics
Oral PresentationInitial Report of RTOG 9601: A Phase III Trial in Prostate Cancer: Anti-androgen Therapy (AAT) with Bicalutamide during and after Radiation Therapy (RT) Improves Freedom from Progression and Reduces the Incidence of Metastatic Disease in Patients following Radical Prostatectomy (RP) with pT2-3, N0 Disease, and Elevated PSA Levels
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Purpose/Objective(s)
To test if long term AAT when combined with RT in these patients with prostate cancer (PC) will improve cancer control outcomes as well as overall survival.
Materials/Methods
Post-RP patients with pT3,N0 or with pT2,N0 (and also positive margins) who have an elevated PSA were entered on a Phase III, double-blinded, placebo-controlled trial of RT alone (64.8 Gy in 36 fractions of 1.8 Gy) Vs RT plus AAT (24 months of bicalutamide, 150mg QD) during and after RT. The primary end-point is overall survival.
Results
From 3/98 to 3/03, 771 eligible patients (median age 65) were randomized to RT plus AAT (387) or RT alone (383). Pretreatment characteristics were balanced. 252 patients (33%) were pT2,N0 and 518 patients (67%) were pT3,N0. 672 patients (87%) had a PSA nadir after RP of < 0.5 ng/mL. 655 patients (85%) had an entry PSA value of <1.6, 115 patients (15%) had an entry PSA of 1.6-3.9. Median follow-up in surviving patients was 7.1 years. The actuarial overall survival at 7 years was 91% for RT plus
Conclusions
The addition of 24 months of peripheral androgen blockade (AAT) during and after RT significantly improved FFP and reduced the incidence of metastatic PC without adding significantly to radiation toxicity. The significance of benefit in overall survival, as well analysis of risk-stratified subsets, must await longer follow-up.
This project was supported by RTOG grant U10 CA21661 and CCOP grant U10 CA37422 from the National Cancer Institute (NCI). This publication's contents are solely the
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Author Disclosure: W.U. Shipley, None; D. Hunt, None; H. Lukka, None; P. Major, None; N.M. Heney, None; D. Grignon, None; M. Patel, None; J. Bahary, None; C. Lawton, None; H. Sandler, None.