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Randomized Controlled Trial
. 2015 Feb 1;33(4):332-9.
doi: 10.1200/JCO.2014.58.0662. Epub 2014 Dec 22.

Duration of androgen suppression before radiotherapy for localized prostate cancer: radiation therapy oncology group randomized clinical trial 9910

Thomas M Pisansky  1 , Daniel Hunt  2 , Leonard G Gomella  2 , Mahul B Amin  2 , Alexander G Balogh  2 , Daniel M Chinn  2 , Michael J Seider  2 , Marie Duclos  2 , Seth A Rosenthal  2 , Glenn S Bauman  2 , Elizabeth M Gore  2 , Marvin Z Rotman  2 , Himanshu R Lukka  2 , William U Shipley  2 , James J Dignam  2 , Howard M Sandler  2
Affiliations
Randomized Controlled Trial

Duration of androgen suppression before radiotherapy for localized prostate cancer: radiation therapy oncology group randomized clinical trial 9910

Thomas M Pisansky et al. J Clin Oncol. .

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.

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.

Trial registration: ClinicalTrials.gov NCT00005044.

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Conflict of interest statement

Authors' disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
Enrollment, random assignment, and follow-up of the study participants. AS, androgen suppression; RT, radiotherapy.
Fig 2.
Fig 2.
Estimates of (A) disease-specific survival and (B) overall survival. AS, androgen suppression; HR, hazard ratio.
Fig 3.
Fig 3.
Estimates of (A) disease-free survival and cumulative incidences of (B) locoregional progression, (C) distant metastasis, and (D) biochemical failure (nadir + 2 ng/mL). AS, androgen suppression; HR, hazard ratio.
See this image and copyright information in PMC

Comment in

References

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