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A Randomized Controlled Trial

Anthony V. D'Amico, MD, PhD; Judith Manola, MS; Marian Loffredo, RN, OCN; Andrew A. Renshaw, MD; Alyssa DellaCroce, BA; Philip W. Kantoff, MD

JAMA. 2004;292:821-827.

Context  Survival benefit in the management of high-grade clinically localized prostate cancer has been shown for 70 Gy radiation therapy combined with 3 years of androgen suppression therapy (AST), but long-term AST is associated with many adverse events.

Objective  To assess the survival benefit of 3-dimensional conformal radiation therapy (3D-CRT) alone or in combination with 6 months of AST in patients with clinically localized prostate cancer.

Design, Setting, and Patients  A prospective randomized controlled trial of 206 patients with clinically localized prostate cancer who were randomized to receive 70 Gy 3D-CRT alone (n = 104) or in combination with 6 months of AST (n = 102) from December 1, 1995, to April 15, 2001. Eligible patients included those with a prostate-specific antigen (PSA) of at least 10 ng/mL, a Gleason score of at least 7, or radiographic evidence of extraprostatic disease.

Main Outcome Measures  Time to PSA failure (PSA >1.0 ng/mL and increasing >0.2 ng/mL on 2 consecutive visits) and overall survival.

Results  After a median follow-up of 4.52 years, patients randomized to receive 3D-CRT plus AST had a significantly higher survival (P = .04), lower prostate cancer–specific mortality (P = .02), and higher survival free of salvage AST (P = .002). Kaplan-Meier estimates of 5-year survival rates were 88% (95% confidence interval [CI], 80%-95%) in the 3D-CRT plus AST group vs 78% (95% CI, 68%-88%) in the 3D-CRT group. Rates of survival free of salvage AST at 5 years were 82% (95% CI, 73%-90%) in the 3D-CRT plus AST group vs 57% (95% CI, 46%-69%) in the 3D-CRT group.

Conclusion  The addition of 6 months of AST to 70 Gy 3D-CRT confers an overall survival benefit for patients with clinically localized prostate cancer.

Author Affiliations: Departments of Radiation Oncology (Dr D'Amico and Ms Loffredo), Biostatistics (Mss Manola and DellaCroce), Pathology (Dr Renshaw), and Medical Oncology (Dr Kantoff), Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, Mass.

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