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Original Contribution
December 1, 2010

Active Surveillance Compared With Initial Treatment for Men With Low-Risk Prostate Cancer: A Decision Analysis

Author Affiliations

Author Affiliations: Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Harvard Medical School (Drs Hayes, Kantoff, and Sweeney), and Institute for Technology Assessment (Drs Hayes, Stahl, and McMahon), Institute for Clinical and Economic Review (Mr Ollendorf and Dr Pearson), and Medical Practices Evaluation Center (Dr Barry), Massachusetts General Hospital, Harvard Medical School, Boston; Harvard University Interfaculty Program for Health Systems Improvement and Na- tional Bureau of Economic Research, Cambridge, Massachusetts (Dr Stewart); Health Services Research and Development, Center for Patient Oriented Care, Veterans Affairs San Diego Health Care System, San Diego, California (Dr Bhatnagar); and Department of Family and Preventive Medicine, University of California San Diego, La Jolla (Dr Bhatnagar).

JAMA. 2010;304(21):2373-2380. doi:10.1001/jama.2010.1720

Context In the United States, 192 000 men were diagnosed as having prostate cancer in 2009, the majority with low-risk, clinically localized disease. Treatment of these cancers is associated with substantial morbidity. Active surveillance is an alternative to initial treatment, but long-term outcomes and effect on quality of life have not been well characterized.

Objective To examine the quality-of-life benefits and risks of active surveillance compared with initial treatment for men with low-risk, clinically localized prostate cancer.

Design and Setting Decision analysis using a simulation model was performed: men were treated at diagnosis with brachytherapy, intensity-modulated radiation therapy (IMRT), or radical prostatectomy or followed up by active surveillance (a strategy of close monitoring of newly diagnosed patients with serial prostate-specific antigen measurements, digital rectal examinations, and biopsies, with treatment at disease progression or patient choice). Probabilities and utilities were derived from previous studies and literature review. In the base case, the relative risk of prostate cancer–specific death for initial treatment vs active surveillance was assumed to be 0.83. Men incurred short- and long-term adverse effects of treatment.

Patients Hypothetical cohorts of 65-year-old men newly diagnosed as having clinically localized, low-risk prostate cancer (prostate-specific antigen level <10 ng/mL, stage ≤T2a disease, and Gleason score ≤6).

Main Outcome Measure Quality-adjusted life expectancy (QALE).

Results Active surveillance was associated with the greatest QALE (11.07 quality-adjusted life-years [QALYs]), followed by brachytherapy (10.57 QALYs), IMRT (10.51 QALYs), and radical prostatectomy (10.23 QALYs). Active surveillance remained associated with the highest QALE even if the relative risk of prostate cancer–specific death for initial treatment vs active surveillance was as low as 0.6. However, the QALE gains and the optimal strategy were highly dependent on individual preferences for living under active surveillance and for having been treated.

Conclusions Under a wide range of assumptions, for a 65-year-old man, active surveillance is a reasonable approach to low-risk prostate cancer based on QALE compared with initial treatment. However, individual preferences play a central role in the decision whether to treat or to pursue active surveillance.