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J Clin Oncol. 2013 Nov 1;31(31):3860-8. doi: 10.1200/JCO.2013.51.1972. Epub 2013 Oct 7.

Randomized trial of hypofractionated external-beam radiotherapy for prostate cancer.

Author information

1
Alan Pollack, Gail Walker, and Radka Stoyanova, University of Miami Miller School of Medicine, Miami, FL; Eric M. Horwitz, Robert Price, Richard E. Greenberg, Robert G. Uzzo, Charlie Ma, and Mark K. Buyyounouski, Fox Chase Cancer Center, Philadelphia, PA; Steven Feigenberg, University of Maryland, Baltimore, MD; Andre A. Konski, Wayne State University Medical Center; and Benjamin Movsas, Henry Ford Hospital, Detroit, MI.

Abstract

PURPOSE:

To determine if escalated radiation dose using hypofractionation significantly reduces biochemical and/or clinical disease failure (BCDF) in men treated primarily for prostate cancer.

PATIENTS AND METHODS:

Between June 2002 and May 2006, men with favorable- to high-risk prostate cancer were randomly allocated to receive 76 Gy in 38 fractions at 2.0 Gy per fraction (conventional fractionation intensity-modulated radiation therapy [CIMRT]) versus 70.2 Gy in 26 fractions at 2.7 Gy per fraction (hypofractionated IMRT [HIMRT]); the latter was estimated to be equivalent to 84.4 Gy in 2.0 Gy fractions. High-risk patients received long-term androgen deprivation therapy (ADT), and some intermediate-risk patients received short-term ADT. The primary end point was the cumulative incidence of BCDF. Secondarily, toxicity was assessed.

RESULTS:

There were 303 assessable patients with a median follow-up of 68.4 months. No significant differences were seen between the treatment arms in terms of the distribution of patients by clinicopathologic or treatment-related (ADT use and length) factors. The 5-year rates of BCDF were 21.4% (95% CI, 14.8% to 28.7%) for CIMRT and 23.3% (95% CI, 16.4% to 31.0%) for HIMRT (P = .745). There were no statistically significant differences in late toxicity between the arms; however, in subgroup analysis, patients with compromised urinary function before enrollment had significantly worse urinary function after HIMRT.

CONCLUSION:

The hypofractionation regimen did not result in a significant reduction in BCDF; however, it is delivered in 2.5 fewer weeks. Men with compromised urinary function before treatment may not be ideal candidates for this approach.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00062309.

PMID:
24101042
PMCID:
PMC3805927
DOI:
10.1200/JCO.2013.51.1972
[Indexed for MEDLINE]
Free PMC Article

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