Since NJM does not see the raw data, and this study was not used for FDA approval (but for marketing purposes) the reasonable conclusion is that at best there was no improvement in survival for short-term use of androgen blocking treat (ADT)--their finding was a 5% improvement. 

http://www.nejm.org/doi/full/10.1056/NEJMoa1012348?query=TOC

Radiotherapy and Short-Term Androgen Deprivation for Localized Prostate Cancer

Christopher U. Jones, M.D., Daniel Hunt, Ph.D., David G. McGowan, M.B., Ch.B., Mahul B. Amin, M.D., Michael P. Chetner, M.D., Deborah W. Bruner, R.N., Ph.D., Mark H. Leibenhaut, M.D., Siraj M. Husain, M.D., Marvin Rotman, M.D., Luis Souhami, M.D., Howard M. Sandler, M.D., and William U. Shipley, M.D.

N Engl J Med 2011; 365:107-118July 14, 2011

Background

It is not known whether short-term androgen-deprivation therapy (ADT) before and during radiotherapy improves cancer control and overall survival among patients with early, localized prostate adenocarcinoma.

Methods

From 1994 through 2001, we randomly assigned 1979 eligible patients with stage T1b, T1c, T2a, or T2b prostate adenocarcinoma and a prostate-specific antigen (PSA) level of 20 ng per milliliter or less to radiotherapy alone (992 patients) or radiotherapy with 4 months of total androgen suppression starting 2 months before radiotherapy (radiotherapy plus short-term ADT, 987 patients). The primary end point was overall survival. Secondary end points included disease-specific mortality, distant metastases, biochemical failure (an increasing level of PSA), and the rate of positive findings on repeat prostate biopsy at 2 years.

Results

The median follow-up period was 9.1 years. The 10-year rate of overall survival was 62% among patients receiving radiotherapy plus short-term ADT (the combined-therapy group), as compared with 57% among patients receiving radiotherapy alone (hazard ratio for death with radiotherapy alone, 1.17; P=0.03). The addition of short-term ADT was associated with a decrease in the 10-year disease-specific mortality from 8% to 4% (hazard ratio for radiotherapy alone, 1.87; P=0.001). Biochemical failure, distant metastases, and the rate of positive findings on repeat prostate biopsy at 2 years were significantly improved with radiotherapy plus short-term ADT. Acute and late radiation-induced toxic effects were similar in the two groups. The incidence of grade 3 or higher hormone-related toxic effects was less than 5%[1]. Reanalysis according to risk showed reductions in overall and disease-specific mortality primarily among intermediate-risk patients, with no significant reductions among low-risk patients.

Conclusions

Among patients with stage T1b, T1c, T2a, or T2b prostate adenocarcinoma and a PSA level of 20 ng per milliliter or less, the use of short-term ADT for 4 months before and during radiotherapy was associated with significantly decreased disease-specific mortality and increased overall survival. According to post hoc risk analysis, the benefit was mainly seen in intermediate-risk, but not low-risk, men. (Funded by the National Cancer Institute; RTOG 94-08 ClinicalTrials.gov number, NCT00002597.)

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Supported by grants (U10 CA21661, to the Radiation Therapy Oncology Group [RTOG]; U10 CA37422, to the Community Clinical Oncology Program; and U10 CA32115, to the RTOG Statistical Center) from the National Cancer Institute.

Dr. Chetner reports receiving lecture fees from and serving on the advisory boards of Amgen, Ferring, GlaxoSmithKline, and Eli Lilly and receiving fees for the development of educational presentations from Amgen and GlaxoSmithKline; and Dr. Sandler, consulting fees from Calypso Medical and Varian.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

No other potential conflict of interest relevant to this article was reported.

Source Information

From Radiological Associates of Sacramento, Sacramento, CA (C.U.J., M.H.L.); the Radiation Therapy Oncology Group Statistical Center (D.H.) and the School of Nursing, University of Pennsylvania, (D.W.B.) — both in Philadelphia; the Department of Radiation Oncology, Cross Cancer Institute, Edmonton (D.G.M.); the Division of Urology, Department of Surgery, University of Alberta, Edmonton (M.P.C.); and the Department of Radiation Oncology, Tom Baker Cancer Centre, Calgary (S.M.H.) — all in Alberta, Canada; the Department of Pathology and Laboratory Medicine (M.B.A.) and the Department of Radiation Oncology, Samuel Oschin Comprehensive Cancer Institute, Cedars–Sinai Medical Center, Los Angeles (H.M.S.); the Department of Radiation Oncology, State University of New York Health Science Center at Brooklyn, Brooklyn (M.R.); the Department of Radiation Oncology, McGill University, Montreal (L.S.); and the Department of Radiation Oncology, Massachusetts General Hospital, Boston (W.U.S.).

Address reprint requests to Dr. Jones at Radiological Associates of Sacramento, 1500 Expo Pkwy., Sacramento, CA 95816, or at jonesc@radiological.com.