Systematic prostatic biopsies in 100 men with no suspicion of cancer on digital rectal examination.

A total of 100 men with a mean age of 63 years underwent, in the following order, prostate specific antigen (PSA) assay (radioimmunometric assay, normal less than 2.5 ng./ml.), rectal examination, transrectal ultrasonography with a 7 MHz. probe, measurement of the prostatic volume, and 6 ultrasound-guided randomized biopsies and biopsies of any hypoechogenic zones. All men with a suspicious prostate on rectal examination (nodule, induration or firm zone) were excluded from the study. There were 14 prostatic cancers detected: 3 (8.5%) in men less than 60 years old, 4 (11%) in men between 60 and 70 years old and 7 (24%) in men more than 70 years old. No cancer was detected in men with a PSA level of less than 10 ng./ml., 5 (26%) were detected in 19 men with a PSA level of 10 to 19 ng./ml., 4 (40%) were detected in 10 men with a PSA of 20 to 29.9 ng./ml. and 5 (100%) were detected in 5 men with a PSA of 30 or more ng./ml. A total of 66 men (66%) had a PSA level of less than 10 ng./ml. There were 18 (18%) hypoechogenic zones detected: 2 (11%) were positive for cancer but, over-all, the hypoechogenic zones revealed cancer in only 2 of 100 cases (2%). In 12 of the 14 cancers detected (86%) with no clinical suspicion the PSA level was higher than the maximal PSA level related to the prostate weight. We conclude that systematic randomized prostatic biopsies are the best method of early diagnosis, detecting 41% of all prostatic cancers in men with a normal rectal examination when the PSA level is 10 ng./ml. or more. The real question is to determine whether this early diagnosis is useful for the patient, since presently, there is no certainty of the therapeutic benefit in terms of quantity and quality of life.