A multicenter study on the detection of prostate cancer by digital rectal examination and prostate-specific antigen in men with or without urinary symptoms

Objective: The use of prostate-specific antigen (PSA) for prostatic cancer screening and the practical utility of the concept of PSA density are controversial. The aim this multicenter study was to assess the usefulness of PSA as a diagnostic procedure for prostate cancer in patients with urinary symptoms, and compare it with digital rectal examination (DRE). Methods: We performed a multicenter study in 18 hospitals to assess the value of PSA in the diagnosis of prostate cancer. 2,054 outpatients, aged above 50 years, were included in the study. Patients with suspected prostatitis or severe systemic disease were excluded. PSA levels were measured in all patients (IMx) and a DRE was also performed. Patients with PSA levels >3 ng/ml and/or a suspicious DRE underwent transrectal ultrasound and a prostate biopsy. Results: PSA levels >3 ng/ml and/or a suspect DRE were found in 680 (33%) patients, in 587 (29%) of whom a biopsy was performed, A cancer of the prostate was diagnosed in 131 patients. The cancer detection rate was 5.89% for PSA >4 ng/ml, 4.38% for DRE and 6.37% for the combination of both methods. The combination of PSA and DRE allows for increasing the diagnostic sensitivity which would be achieved with either test alone. Conclusion: We recommended the use of PSA and DRE in combination as a diagnostic procedure for prostate cancer, since these are complementary methods which allow for detecting a population at a high risk of suffering prostate cancer.