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Clinical Question
In men with symptomatically detected prostate cancer, does radical prostatectomy reduce mortality compared with watchful waiting?
Bottom line
Although at first glance the results of this trial may appear to strengthen the argument in favor of prostate cancer screening using a prostate-specific antigen (PSA) test, it is important to clarify that this was not a screening study. Also, the patients had a much higher PSA result (mean 13 vs median 4.8 ng/mL) and stage (mostly T2 vs mostly T1c) than patients in the recent ProtecT trial. Also, the "watchful waiting" in this study was not the same as the contemporary practice of active surveillance. This study does tell us that for men presenting because of symptoms, who are diagnosed with stage T2 prostate cancer, and have a fairly high PSA level, surgery reduces mortality compared with doing nothing. 1b-
Reference
Study design: Randomized controlled trial (single-blinded)
Funding: Government
Setting: Outpatient (specialty)
Synopsis
These researchers identified 695 patients who had their cancer detected because they presented with symptoms. Approximately half had a PSA test result greater than 10 ng/mL (mean 13 ng/mL), and three-quarters were stage T2. The patients were recruited between 1989 and 1999 in Sweden, Finland, and Iceland and were randomized to receive radical prostatectomy or watchful waiting. The latter consisted of annual physician visits, with local progression defined as palpable transcapsular tumor or symptomatic obstruction of urine flow requiring treatment. After a median follow-up of 23.6 years, prostate cancer–specific and all-cause mortality were both approximately 12% lower in the radical prostatectomy group (number needed to treat [NNT] = 8 to prevent one death), with a mean 2.9 years of life gained. The likelihood of distant metastases was also lower in the radical prostatectomy group (26.6% vs 43.3%; P < .001; NNT = 6). The survival benefit was greater for men younger than 65 years, with an absolute mortality difference of 15% versus 10% in older patients. No information about harms, such as surgical mortality, complications, incontinence, or impotence, was reported.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA