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EVERAL RANDOMIZED STUDIES [1][2][3][4][5] have documented a prolongation in overall survival, prostate cancer-specific survival, or both when androgen suppression therapy (AST) is combined with external beam radiation therapy (RT) compared with RT alone in the management of unfavorable localized and locally advanced prostate cancer. Therefore, in men with these stages of disease, RT and AST have become a standard of care.However, evidence from pooled analyses of randomized studies 6 as well as large patient cohort studies 7,8 suggests that AST administration is associated with an increased risk of fatal 6 and nonfatal 7,8 cardiovascular events in men of advanced age. A possible explanation for this association is that as men age, they often acquire comorbid illnesses and these comorbidities may increase the negative effects of specific anticancer treatments such as AST. As a result, it is possible that the survival benefit observed when AST is added to RT may vary among specific subsets of patients defined by their comorbid illness profile.In this study, we first report the results of the long-term follow-up of a randomized study of 6 months of AST and RT vs RT alone. The results of shorterterm follow-up, ie, at 4.5 years, have been previously reported. 5 In addition, we performed an analysis of overall survival in subgroups defined by their level of comorbidity at the time of randomization and evaluated whether an interaction existed between the level of comorbidity and treatment group with respect to time to all-cause mortality. METHODSPatient Population and Treatment At academic (Dana-Farber Cancer Institute, Brigham and Women's Hospital, and Beth Israel Deaconess Medical Center) and community-based (St Anne's Hospital, Metrowest Medical Center, and Suburban Oncology Center) medical centers in Massachusetts,

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The use of ADT appears to be associated with an increased risk of death from cardiovascular causes in patients undergoing radical prostatectomy for localized prostate cancer.

The use of AST is associated with earlier onset of fatal MIs in men age 65 years or older who are treated for 6 months compared with men who are not treated with AST.

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A post-treatment PSA-DT of less than 3 months and the specific value of the post-treatment PSA-DT when it is 3 months or more appear to be surrogate end points for prostate cancer-specific mortality after surgery or radiation therapy. We recommend that consideration be given to initiating androgen suppression therapy at the time of a PSA-defined recurrence when the PSA-DT is less than 3 months to delay the imminent onset of metastatic bone disease.