Biopsy-proved prostate cancer in 100 consecutive men with benign digital rectal examination and elevated serum prostate-specific antigen level. Prevalence and pathologic characteristics.

To determine whether a significant percentage of patients with a benign digital rectal examination (DRE) and an elevated serum prostate-specific antigen (PSA) level harbor a prostatic malignancy, 100 consecutive patients underwent transrectal ultrasound (TRUS)-guided biopsy of the prostate. The biopsy results were correlated with the pre-biopsy serum PSA level and ultrasound findings. Overall, the cancer detection rate was 35 percent (S.E. 4.8%). When the biopsy results were analyzed according to the PSA level, the rate of cancer detection increased with advancing PSA levels, irrespective of ultrasound findings. In the 60 patients with ultrasound abnormalities, the cancer detection rate was 47 percent compared with 18 percent for those without ultrasound abnormalities. Comparison of TRUS-negative and TRUS-positive biopsy results revealed a more than two-fold increase in cancer detection for the TRUS-positive group in each PSA range. Cancer detection in the TRUS-positive, PSA 4.1-10, 10.1-20.0, and > 20 ng/mL groups was 40 percent, 56 percent, and 67 percent, respectively; in the TRUS-negative group, cancer detection was 12 percent, 27 percent, and 33 percent, respectively. Twenty (57%) of the patients with prostate cancer underwent radical retropubic prostatectomy. The mean tumor volume was 4.7 cc. Seventy percent had organ-confined disease, 30 percent demonstrated capsular penetration only, and no patients had seminal vesicle or pelvic lymph node invasion. These data indicate that a significant percentage of patients with a benign DRE and an elevated serum PSA value harbor a clinically significant, but potentially curable prostatic malignancy.