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

Authors

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

Publication/Presentation Date

2-1-2015

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.

Volume

33

Issue

4

First Page

332

Last Page

339

ISSN

1527-7755

Published In/Presented At

Pisansky, T. M., Hunt, D., Gomella, L. G., Amin, M. B., Balogh, A. G., Chinn, D. M., Seider, M. J., Duclos, M., Rosenthal, S. A., Bauman, G. S., Gore, E. M., Rotman, M. Z., Lukka, H. R., Shipley, W. U., Dignam, J. J., & Sandler, H. M. (2015). Duration of androgen suppression before radiotherapy for localized prostate cancer: radiation therapy oncology group randomized clinical trial 9910. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 33(4), 332–339. https://doi.org/10.1200/JCO.2014.58.0662

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

25534388

Department(s)

Administration and Leadership

Document Type

Article