Duration of androgen suppression before radiotherapy for localized prostate cancer: Radiation Therapy Oncology Group randomized clinical trial 9910 - Abstract

PURPOSE: To determine whether prolonged androgen suppression (AS) duration before radiotherapy improves survival and disease control in prostate cancer.

PATIENTS AND METHODS: One thousand five hundred seventy-nine men with intermediate-risk prostate cancer were randomly assigned to 8 weeks of AS followed by radiotherapy with an additional 8 weeks of concurrent AS (16 weeks total) or to 28 weeks of AS followed by radiotherapy with an additional 8 weeks of AS (36 weeks total). The trial sought primarily to detect a 33% reduction in the hazard of prostate cancer death in the 28-week assignment. Time-to-event end points are reported for up to 10 years of follow-up.

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RESULTS: There were no between-group differences in baseline characteristics of 1,489 eligible patients with follow-up. For the 8- and 28-week assignments, 10-year disease-specific survival rates were 95% (95% CI, 93.3% to 97.0%) and 96% (95% CI, 94.6% to 98.0%; hazard ratio [HR], 0.81; P = .45), respectively, and 10-year overall survival rates were 66% (95% CI, 62.0% to 69.9%) and 67% (95% CI, 63.0% to 70.8%; HR, 0.95; P = .62), respectively. For the 8- and 28-week assignments, 10-year cumulative incidences of locoregional progression were 6% (95% CI, 4.3% to 8.0%) and 4% (95% CI, 2.5% to 5.7%; HR, 0.65; P = .07), respectively; 10-year distant metastasis cumulative incidences were 6% (95% CI, 4.0% to 7.7%) and 6% (95% CI, 4.0% to 7.6%; HR, 1.07; P = .80), respectively; and 10-year prostate-specific antigen-based recurrence cumulative incidences were 27% (95% CI, 23.1% to 29.8%) and 27% (95% CI, 23.4% to 30.3%; HR, 0.97; P = .77), respectively.

CONCLUSION: Extending AS duration from 8 weeks to 28 weeks before radiotherapy did not improve outcomes. A lower than expected prostate cancer death rate reduced ability to detect a between-group difference in disease-specific survival. The schedule of 8 weeks of AS before radiotherapy plus 8 weeks of AS during radiotherapy remains a standard of care in intermediate-risk prostate cancer.

Written by:
Pisansky TM, Hunt D, Gomella LG, Amin MB, Balogh AG, Chinn DM, Seider MJ, Duclos M, Rosenthal SA, Bauman GS, Gore EM, Rotman MZ, Lukka HR, Shipley WU, Dignam JJ, Sandler HM   Are you the author?
Thomas M. Pisansky, Mayo Clinic, Rochester, MN; Daniel Hunt and James J. Dignam, Radiation Therapy Oncology Group Statistical Center; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center, Los Angeles; Daniel M. Chinn, John Muir Medical Center-Concord Campus, Concord; Seth A. Rosenthal, Sutter Medical Group, Sacramento, CA; Michael J. Seider, Akron City Hospital, Akron, OH; Elizabeth M. Gore, Zablocki Veterans Administration Medical Center-Wood, Milwaukee, WI; Marvin Z. Rotman, Brooklyn Minority-Based Community Clinical Oncology Program, State University of New York Downstate, Brooklyn, NY; William U. Shipley, Massachusetts General Hospital, Boston, MA; James J. Dignam, University of Chicago, Chicago, IL; Alexander G. Balogh, Tom Baker Cancer Centre, Calgary, Alberta; Marie Duclos, McGill University, Montreal, Quebec; Glenn S. Bauman, London Regional Cancer Program, London; and Himanshu R. Lukka, McMaster University, Hamilton, Ontario, Canada. Thomas M. Pisansky, Mayo Clinic, Rochester, MN; Daniel Hunt and James J. Dignam, Radiation Therapy Oncology Group Statistical Center; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Mahul B. Amin and Howard M. Sandler, Cedars-Sinai Medical Center, Los Angeles; Daniel M. Chinn, John Muir Medical Center-Concord Campus, Concord; Seth A. Rosenthal, Sutter Medical Group, Sacramento, CA; Michael J. Seider, Akron City Hospital, Akron, OH; Elizabeth M. Gore, Zablocki Veterans Administration Medical Center-Wood, Milwaukee, WI; Marvin Z. Rotman, Brooklyn Minority-Based Community Clinical Oncology Program, State University of New York Downstate, Brooklyn, NY; William U. Shipley, Massachusetts General Hospital, Boston, MA; James J. Dignam, University of Chicago, Chicago, IL; Alexander G. Balogh, Tom Baker Cancer Centre, Calgary, Alberta; Marie Duclos, McGill University, Montreal, Quebec; Glenn S. Bauman, London Regional Cancer Program, London; and Himanshu R. Lukka, McMaster University, Hamilton, Ontario, Canada.  

Reference: J Clin Oncol. 2015 Feb 1;33(4):332-9
doi: 10.1200/JCO.2014.58.0662


PubMed Abstract
PMID: 25534388

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