Management of low risk and low PSA prostate cancer: long term results from the prostate cancer intervention versus observation trial.

Management of localized prostate cancer is controversial due in part to the lack of randomized controlled trial information in men diagnosed with prostate specific antigen (PSA) testing. Men with low risk or low PSA (<10 ng/ml) prostate cancer comprise up to 70 % of men currently diagnosed. Evidence suggests an excellent long-term prognosis with observation though nearly 90 % are treated with surgery (radical prostatectomy), external beam radiation, or brachytherapy. Results from the Prostate cancer Intervention Versus Observation Trial (PIVOT) provide high quality Level 1 evidence that observation compared to surgery results in similar long-term overall and prostate cancer survival, prevention of bone metastases and avoidance of surgery related harms. Combined with emerging evidence from screening, natural history, decision analysis and cost-effectiveness modeling studies, these data demonstrate that observation is the preferred treatment option for men with low risk and possibly low PSA prostate cancer. Recommending against PSA testing or, in men who still desire testing, raising thresholds of PSA values used to define abnormal, lengthening intervals between PSA tests and discontinuing testing in men with a life expectancy less than 15 years will reduce diagnostic and treatment related harms without adversely impacting overall or disease specific mortality and morbidity.