Screening decreases prostate cancer death: First analysis of the 1988 Quebec Prospective Randomized Controlled Trial

BACKGROUND: The 46,193 men aged 45 to 80 years registered in the electoral roll of Quebec City and its Metropolitan area were randomized in November 1988 between screening and no screening in a study aimed of assessing the impact of prostate cancer screening on cause-specific death. METHODS: At first visit, screening included measurement of serum prostatic specific antigen (PSA) using 3.0 ng/ml as upper limit of normal and a digital rectal examination (DRE). Transrectal echography of the prostate (TRUS) was performed only if PSA and/or DRE was abnormal and biopsy was then done, only if PSA was above the predicted PSA value. At follow-up visits, PSA alone was used as prescreening. RESULTS: 137 deaths due to prostate cancer occurred between 1989 and 1996, inclusively, in the 38,056 unscreened men while only 5 deaths were observed among the 8,137 screened individuals. The prostate cancer death rates during the eight-year period were 48.7 and 15 per 100,000 man-years in the unscreened and screened groups, respectively, for a 3.25 odds ratio in favor of screening and early treatment (P < 0.01). CONCLUSIONS: If PSA screening is started at the age of 50 years (or 45 years in the higher risk population), annual or biannual PSA alone is highly efficient to identify the men who are at high risk of having prostate cancer. Coupled with treatment of localized disease, this approach demonstrates, for the first time, that early diagnosis and treatment permits a dramatic decrease in deaths from prostate cancer.