PSA, PSA density, PSA density of transition zone, free/total PSA ratio, and PSA velocity for early detection of prostate cancer in men with serum PSA2.5 to 4.0 ng/ml

Objectives. To enhance the specificity of prostate cancer (PCa) detection a nd reduce unnecessary biopsies in men with prostate-specific antigen (PSA) levels of 2.5 to 4.0 ng/mL, we prospectively evaluated various PSA-based di agnostic parameters. Methods. This study included 273 consecutive men with serum PSA of 2.5 to 4 .0 ng/mL referred for early PCa detection or lower urinary tract symptoms. All men underwent prostate ultrasound and sextant biopsy with two additiona l transition zone (TZ) biopsies. If the first biopsies were negative, repea ted biopsies were performed at 6 weeks. Total PSA, PSA density (PSAD), PSA density of the transition zone (PSA-TZ), free/total PSA ratio (fit PSA), an d PSA velocity (PSAV) were determined, and the sensitivity, specificity, an d predictive values of these various parameters were calculated. Results. Of 273 patients, 207 had histologically confirmed benign prostatic hyperplasia (BPH) and 66 had PCa. fit PSA and PSA-TZ were the most powerfu l predictors of PCa, followed by PSA, PSAD, and PSAV. Areas under the recei ver operating characteristic curves for fit PSA and PSA-TZ were 74.9% and 7 0.1%, respectively. With a 95% sensitivity for PCa detection, an f/t PSA cu toff of 41% and a PSA-TZ cutoff of 0.095 would result in the lowest number of unnecessary biopsies (29.3% and 17.2% specificity for fit PSA and PSA-TZ , respectively) compared with all other PSA-related parameters evaluated. Conclusions. Compared with standard total PSA assays, fit PSA and PSA-TZ si gnificantly enhance the sensitivity and specificity of PCa detection in a r eferral patient population with a total PSA of 2.5 to 4.0 ng/mL. (C) 1999, Elsevier Science Inc.