Objectives: Family history has been identified as a risk factor for prostate cancer. We assessed the risk of prostate cancer in men with a positive family history (at least one first-degree or second-degree relative), normal digital rectal examination (DRE) and a serum prostate-specific antigen (PSA) level of 4.0 ng/mL. Methods: A total of 87 volunteers from the San Antonio Center of biomarkers of risk for prostate cancer study enrolled in a prospective study to assess the prevalence of prostate cancer in men with a family history of prostate cancer, normal DRE findings, and a serum PSA level of 4.0 ng/mL or less. All subjects underwent transrectal ultrasound-guided prostate biopsy. Results: Prostate cancer was diagnosed in 22 (25.3%) of the 87 participants. The PSA values were significantly greater statistically in the men with prostate cancer (median 2.1 ng/mL) than in the men without prostate cancer (median 1.2 ng/mL, P = 0.01), and the odds of prostate cancer nearly doubled for a doubling of the PSA level within this interval (odds ratio 1.97, P = 0.02). No statistically significant difference was found in age, race, or number and type of affected relatives in men with and without prostate cancer. Conclusions: The results of our study have demonstrated a high frequency of prostate cancer in men with a positive family history but normal DRE findings and a PSA level of 4.0 ng/mL or less. These prospectively collected data raise an important consideration regarding lowering the PSA cutoff values for offering biopsy in patients with a positive family history and normal DRE findings.
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