Clinical question Does screening with prostate-specific antigen (PSA) reduce mortality?
Bottom line The initial results of the Prostate Lung Cancer Ovary (PLCO) screening trial found no benefit as measured by prostate cancer-specific mortality. Although this study does not report quality-of-life data or consequences of treatment, such as impotence and incontinence, there were almost 500 more cases of cancer found in the screened group, so screening is an important issue. Men should only choose PSA screening if they understand the lack of proven mortality benefit even in this very large study. (Level of evidence = 1b)
Synopsis Men aged 55 to 74 years at 10 centers were randomized to annual PSA screening for 6 years plus digital rectal examination (DRE) for 4 years, or no screening. Patients with a history of prostate, lung, colon, or ovarian cancer or a PSA in the previous 3 years were not eligible for the study. Further testing was done in the event of a PSA greater than 4.0 ng/mL or an abnormal DRE. Cancer diagnoses were determined by annual mailed surveys, and cancer-specific and allcause mortality were determined by review of death certificates. A total of 76,693 patients were enrolled in the study; 86% were non-Hispanic white, 7% had a family history of prostate cancer, and they were well distributed across the age range. There was considerable contamination, which would tend to dampen any benefit of screening. The rate of PSA screening was 85% in the screening group, it was 40% to 52% in the control group (increasing between years 1 and 6). At this time, there has been complete follow-up for 7 years and partial follow-up for 10 years. Data collection will continue until all patients have had at least 13 years of follow-up. Diagnosis of prostate cancer was significantly more common in the screening group (3,452 vs 2,974 persons, or 9.0% vs 7.7%); most were stage II and more than half had a Gleason score of 5 or 6. There was no difference between groups in patients with advanced cancers. Additionally, there was little difference in prostate cancerspecific mortality between groups (92 in the screening group and 82 in the control group). There was also no difference in all-cause mortality.
Andriole GL, Crawford ED, Grubb RL 3rd, et al; PLCO Project Team. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009;360(13):1310-1319.