Originally published as JCO Early Release 10.1200/JCO.2007.14.9021 on April 14 2008

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Ten-Year Follow-Up of Radiation Therapy Oncology Group Protocol 92-02: A Phase III Trial of the Duration of Elective Androgen Deprivation in Locally Advanced Prostate Cancer

Eric M. Horwitz, Kyounghwa Bae, Gerald E. Hanks, Arthur Porter, David J. Grignon, Harmar D. Brereton, Varagur Venkatesan, Colleen A. Lawton, Seth A. Rosenthal, Howard M. Sandler, William U. Shipley

From the Department of Radiation Oncology, Fox Chase Cancer Center; Department of Biostatistics, Radiation Therapy Oncology Group, Philadelphia; Northeast Radiation Oncology Center, Scranton, PA; Department of Radiation Oncology, McGill University, Montréal, Québec; Department of Radiation Oncology, University of Western Ontario, London, Ontario, Canada; Department of Pathology, Indiana University, Indianapolis, IN; Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI; Department of Radiation Oncology, Radiological Associates of Sacramento, Sacramento, CA; Department of Radiation Oncology, University of Michigan, Ann Arbor, MI; and the Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA

Corresponding author: Eric M. Horwitz, MD, Fox Chase Cancer Center, Department of Radiation Oncology, 333 Cottman Ave, Philadelphia, PA 19111-2497; e-mail: eric.horwitz{at}fccc.edu

Purpose To determine whether adding 2 years of androgen-deprivation therapy (ADT) improved outcome for patients electively treated with ADT before and during radiation therapy (RT).

Patients and Methods Prostate cancer patients with T2c-T4 prostate cancer with no extra pelvic lymph node involvement and prostate-specific antigen (PSA) less than 150 ng/mL were included. All patients received 4 months of goserelin and flutamide before and during RT. They were randomized to no further ADT (short-term ADT [STAD] + RT) or 24 months of goserelin (long-term ADT [LTAD] + RT). A total of 1,554 patients were entered. RT was 45 Gy to the pelvic nodes and 65 to 70 Gy to the prostate. Median follow-up of all survival patients is 11.31 and 11.27 years for the two arms.

Results At 10 years, the LTAD + RT group showed significant improvement over the STAD + RT group for all end points except overall survival: disease-free survival (13.2% v 22.5%; P < .0001), disease-specific survival (83.9% v 88.7%; P = .0042), local progression (22.2% v 12.3%; P < .0001), distant metastasis (22.8% v 14.8%; P < .0001), biochemical failure (68.1% v 51.9%; P .0001), and overall survival (51.6% v 53.9%, P = .36). One subgroup analyzed consisted of all cancers with a Gleason score of 8 to 10 cancers. An overall survival difference was observed (31.9% v 45.1%; P = .0061), as well as in all other end points herein.

Conclusion LTAD as delivered in this study for the treatment of locally advanced prostate cancer is superior to STAD for all end points except survival. A survival advantage for LTAD + RT in the treatment of locally advanced tumors with a Gleason score of 8 to 10 suggests that this should be the standard of treatment for these high-risk patients.

published online ahead of print at www.jco.org on April 14, 2008

Supported by Grants No. RTOG U10 CA21661, CCOP U10 CA37422, and STAT U10 CA32115 from the National Cancer Institute.

Presented at the 48th Annual Meeting of the American Society for Therapeutic Radiology and Oncology, November 5-9, 2006, Philadelphia, PA.

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.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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