Objectives. To examine biochemical progression-free survival (PFS) rates as a function of preoperative prostate-specific antigen (PSA) in patients with clinical Stage T1c prostate cancer treated with radical prostatectomy. Controversy exists about whether performing prostate biopsies for PSA levels in the 2.6 to 4.0 ng/mL range provides a PFS advantage compared with detection at higher PSA ranges. Methods. A total of 2804 men with clinical Stage T1c prostate cancer were treated with radical retropubic prostatectomy and monitored prospectively. The study parameters included preoperative PSA level, pathologic tumor stage, and Gleason grade. Patients were grouped into four clinically relevant strata according to their preoperative PSA level: 2.6 to 4.0, 4.1 to 7.0, 7.1 to 10.0, and greater than 10 ng/mL. The primary outcome was the 10-year actuarial biochemical PFS estimate generated using the Kaplan-Meier method. We compared the strata using the log-rank test. Cancer progression rates were compared using the Cochran Armitage test for trend. The chi-square test was used to compare the pathologic parameters among the PSA strata. Results. Of the men with a preoperative PSA level of 2.6 to 4.0, 4.1 to 7.0, 7.1 to 10.0, and greater than 10.0 ng/mL, 81%, 74%, 72%, and 60%, respectively, had organ-confined disease (P = 0.001) and 23%, 28%, 35%, and 47%, respectively, had a pathologic Gleason grade of 7 or greater (P = 0.001). The corresponding 10-year PFS estimates were 88%, 80%, 76%, and 61% (P = 0.0001, for trend). Conclusions. Among men with clinical Stage T1c prostate cancer, those with a PSA level of 2.6 to 4.0 ng/mL had the greatest rate of organ-confined disease, lowest pathologic Gleason grade, and greatest 10-year PFS rate.
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