Originally published as JCO Early Release 10.1200/JCO.2008.21.5228 on August 10 2009

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Risk Assessment Among Prostate Cancer Patients Receiving Primary Androgen Deprivation Therapy

Matthew R. Cooperberg, Shiro Hinotsu, Mikio Namiki, Kazuto Ito, Jeanette Broering, Peter R. Carroll, Hideyuki Akaza

From the Department of Urology, University of California, San Francisco; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA; Department of Pharmacoepidemiology, Kyoto University, Kyoto; Department of Urology, Kanazawa University School of Medicine, Kanazawa; Department of Urology, Gunma University, Maebashi, Gunma; and Department of Urology, Faculty of Medicine, Institute of Clinical Medicine, University of Tsukuba, Tsukuba, Japan.

Corresponding author: Matthew R. Cooperberg, MD, MPH, University of California, San Francisco, Box 1695, 1600 Divisadero St, A-607, San Francisco, CA 94143-1695; e-mail: mcooperberg{at}urology.ucsf.edu.

Purpose Prostate cancer epidemiology has been marked overall by a downward risk migration over time. However, in some populations, both in the United States and abroad, many men are still diagnosed with high-risk and/or advanced disease. Primary androgen deprivation therapy (PADT) is frequently offered to these patients, and disease risk prediction is not well-established in this context. We compared risk features between large disease registries from the United States and Japan, and aimed to build and validate a risk prediction model applicable to PADT patients.

Methods Data were analyzed from 13,740 men in the United States community-based Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) registry and 19,265 men in the Japan Study Group of Prostate Cancer (J-CaP) database, a national Japanese registry of men receiving androgen deprivation therapy. Risk distribution was compared between the two datasets using three well-described multivariable instruments. A novel instrument (Japan Cancer of the Prostate Risk Assessment [J-CAPRA]) was designed and validated to be specifically applicable to PADT patients, and more relevant to high-risk patients than existing instruments.

Results J-CaP patients are more likely than CaPSURE patients to be diagnosed with high-risk features; 43% of J-CaP versus 5% of CaPSURE patients had locally advanced or metastatic disease that could not be stratified with the standard risk assessment tools. J-CAPRA—scored 0 to 12 based on Gleason score, prostate-specific antigen level, and clinical stage—predicts progression-free survival among PADT patients in J-CaP with a c-index of 0.71, and cancer-specific survival among PADT patients in CaPSURE with a c-index of 0.84.

Conclusion The novel J-CAPRA is the first risk instrument developed and validated for patients undergoing PADT. It is applicable to those with both localized and advanced disease, and performs well in diverse populations.

M.R.C. and S.H. contributed equally to this article.

The Cancer of the Prostate Strategic Urologic Research Endeavor was supported until 2007 by TAP Pharmaceutical Products Inc (Lake Forest, IL), and currently is funded internally by the University of California, San Francisco Department of Urology. The Japan Study Group of Prostate Cancer (J-CaP) project is supported in part by Takeda Pharmaceutical Company Limited (Tokyo, Japan). This work was also supported by National Institutes of Health/National Cancer Institute University of California-San Francisco Specialized Program of Research Excellence p50 c89520.

Presented in part at the Annual Meeting of the American Urological Association April 25-30, 2009, Chicago, IL.

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

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