Objectives: To determine the prevalence of prostate cancer in hypogonadal men with a prostate-specific antigen (PSA) level of 4.0 ng/mL or less.
Methods: A total of 345 consecutive hypogonadal men with a PSA level of 4.0 ng/mL or less underwent evaluation with digital rectal examination and prostate biopsy before initiating a program of testosterone replacement therapy. All men had low serum levels of total or free testosterone, defined as less than 300 and 1.5 ng/dL, respectively.
Results: Cancer was identified in 15.1%. The cancer detection rate was 5.6%, 17.5%, 26.4%, and 36.4% for a PSA level of 1.0 or less, 1.1 to 2.0, 2.1 to 3.0, and 3.1 to 4.0 ng/mL, respectively (P < 0.05). Cancer was detected in 26 (30.2%) of 86 men with a PSA level of 2.0 to 4.0 ng/mL. Cancer was detected in 21% of men with a testosterone level of 250 ng/dL or less compared with 12% of men with a testosterone level greater than 250 ng/dL (P = 0.04). Men with free testosterone levels of 1.0 ng/dL or less had a cancer rate of 20% compared with 12% for men with greater values (P = 0.04). The odds ratio of cancer detection for men in the lowest tertile compared with the highest tertile was 2.15 (95% confidence interval 1.01 to 4.55) for total testosterone and 2.26 (95% confidence interval 1.07 to 4.78) for free testosterone.
Conclusions: Prostate cancer was present in more than 1 of 7 hypogonadal men with PSA of 4.0 ng/mL or less. An increased risk of prostate cancer was associated with more severe reductions in testosterone.