Radical prostatectomy is the most cost-effective primary treatment modality for men diagnosed with high-risk prostate cancer

Prostate cancer is a common malignancy with 913 000 new cases and 215 000 deaths worldwide in 2008. 1 Risk stratification systems are widely used to assist with patient counselling and guide treatment selection risk, as well to ensure prognostic uniformity in clinical trials and in the evaluation of treatment outcomes.Based on work by D'Amico and colleagues, the Genitourinary Radiation Oncologists of Canada (GUROC) developed a classification system for patients with localized/locally advanced disease based on T category, prostate-specific antigen (PSA) level at diagnosis and Gleason score. 2,3 High-risk disease is defined as the presence of any of these factors: cT3 or cT4 category, PSA >20 ng/mL or Gleason score ≥8.Patients studied in clinical trials of "high-risk prostate cancer" represent a very heterogeneous group; this group includes patients with clinically organ-confined disease (cT1/T2) with high Gleason score, and/or PSA and also those with locally advanced disease.In the landmark EORTC (European Organisation for Research and Treatment of Cancer) 22863 trial, overall survival (OS) and local control were considerably improved with the use of 3 years of adjuvant androgen deprivation therapy (ADT) when given with external beam radiotherapy (EBRT) in patients with high-risk locally advanced disease (90% had cT3/T4). 4 With a median follow-up of 9.1 years, the survival advantage for combination treatment was substantial with a 10-year OS of 58% in the combined treatment group compared with 40% in the radiotherapy (RT)-only group.However, despite the fact that combined modality treatment was superior to RT alone, the value of local treatment with RT remained under question as it was felt that the benefit seen may have been due to the early introduction of ADT.This has now been explored in three randomized trials (Table 1). [5]6][7] The National Cancer Institute of Canada (NCIC) PR3/ Canadian Urologic Oncology Group (CUOG)/Medical Research Council (MRC) UK PR07 study randomized 1205 patients with high-risk, locally advanced disease to treatment with combined modality therapy (RT and lifelong ADT) or treatment with ADT alone. 5With a median follow-up of 6 years, combined modality treatment resulted in a 23% reduction in overall mortality and a 46% reduction in disease-specific mortality (Fig. 1).There was a 70% reduction in disease progression with the addition of RT, and local disease progression as a first manifestation of overall progression was reduced from 39% to 15%.The side effects of RT were of modest clinical magnitude and serious long-term genitourinary or gastrointestinal toxicity was uncommon.Patient-reported outcomes also showed that the negative impact of RT on bowel function was of modest clinical magnitude, with recovery scores matching those of patients without RT by 36 months. 8 Similar data have been reported by Widmark and colleagues in the SPCG-7 study; 875 patients with prostate cancer were randomized to endocrine therapy alone or endocrine therapy and EBRT. 6 With a median follow-up of 7.6 years, the cumulative incidence at 10 years for prostate-cancer-specific mortality was 23.9% in the endocrine alone group and 11.9% in the endocrine plus RT group.At 10 years, the cumulative incidence for overall mortality was 39.4% in the endocrine alone group and 29.6% in the endocrine plus RT group for a relative risk of death of 0.6.Urinary, rectal and sexual problems were slightly more frequent in the endocrine plus RT group.About 80% of patients in this study had locally advanced disease.Although this trial, like the NCIC PR3/MRC-UK PR07 study, addressed the issue of impact of RT on survival, there were some differences between the studies.Patients in the SPCG-7 trial had a favourable prognosis.The maximum allowable PSA for trial entry was 70 ng/ml and patients with PSA >11 ng/mL were surgically staged and those with positive pelvic nodes on histological examination were excluded from the study.There were also some differences in the treatment between

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