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Urology evaluation and consideration of 6-quadrant biopsy PSA, consideration of urology evaluation

Using PSA level >4ng/mL as positive and "clinically significant disease" as outcome of detection.

Specificity figures are ambiguous because biopsy of any prostate in men >50 years may find cancer, but not necessarily disease.

defined as 4 nanograms per milliliter (ng/L). Using that definition, sensitivity of the PSA test for cancer occurring within 2 years is about 73%.11 Between 4% of men in their fifties and 27% of men in their seventies will test positive based on this definition.11 DRE finds localized cancer only 50% to 60% of the time.11 Although investigators are looking for proteins that may provide more sensitive and specific prostate cancer screening tests, none have been found and reported to date.

Summary of the Evidence for the Benefit of Prostate Screening Tests

According to the USPSTF, the evidence that prostate cancer screening with either DRE or PSA testing is beneficial for reducing prostate cancer mortality is not convincing.11,150 The only published study of PSA designed as a randomized trial reported a screening benefit but did not maintain the randomized groups (screen, control) in their analysis (Table 24.8).151 When other authors reanalyze the data maintaining the original randomized groups intended for screening and control populations, the benefit is not apparent.11 In observational studies, several factors make it difficult to determine whether finding prostate cancer early truly increases the length of life for men who are diagnosed: (1) the long lead time for prostate cancer, (2) the significant proportion of men who will develop some form of the disease, and (3) biases inherent in following cancer cases.

Demonstrating a benefit for prostate cancer screening is important because serious consequences are associated with overtreatment. Radical prostatectomy has a significant morbidity, including total incontinence (10%), partial incontinence (14%), requiring pads to stay dry (28%), diarrhea (21%), erection insufficient for intercourse (80%), and being bothered by sexual dysfunction (53% to 59%, depending upon age).144 Radiation therapy also has a substantial morbidity that includes total incontinence (3%), partial incontinence (2%), requiring pads to stay dry (3%), diarrhea (37%), erection insufficient for intercourse (62%), and being bothered by sexual dysfunction (40% to 47%, depending upon age).152 Large randomized trials are currently under way in the United States, Austria, and Canada to evaluate the benefits of screening with PSA.153

Recommendations

The USPSTF report concludes that there is insufficient evidence to recommend either for or against screening with PSA.

The ACS recommends offering PSA and DRE annually beginning at age 50 among men who have a life expectancy of at least 10 additional years, but only after appropriate discussion of risks and benefits.10

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