Diagnostic Properties of Total and Free Prostate-Specific Antigen to Predict Overall and Clinically Significant Prostate Cancer Among Men With Low Testosterone and Prior Negative Biopsy

• Published in: Urology (Ridgewood, N.J.) Vol. 137; pp. 97 - 101
• Main Authors: Schwarzman, Logan S., Pagani, Rodrigo L., Ohlander, Samuel J., Mima, Mahmoud, Abern, Michael R., Andriole, Gerald L., Freedland, Stephen J., Moreira, Daniel M.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2020
• Subjects: 5-alpha Reductase Inhibitors - therapeutic use; Aged; Biopsy - methods; Double-Blind Method; Dutasteride - therapeutic use; Early Detection of Cancer - methods; Humans; Male; Middle Aged; Neoplasm Grading; Outcome Assessment, Health Care; Prostate - pathology; Prostate-Specific Antigen - blood; Prostatic Neoplasms - blood; Prostatic Neoplasms - diagnosis; Prostatic Neoplasms - pathology; Sensitivity and Specificity; Testosterone - blood
• ISSN: 0090-4295; 1527-9995; 1527-9995
• DOI: 10.1016/j.urology.2019.11.004

To evaluate whether total serum PSA, free-PSA ratio and PSA density have similar diagnostic properties for detecting prostate cancer (PCa) and clinically-significant (cs) PCa in men with normal testosterone compared to men with low testosterone with a prior negative biopsy. We conducted a retrospective analysis of 3295 men undergoing a 2-year prostate biopsy following a negative prestudy biopsy in the placebo arm of the Reduction by Dutasteride of PCa Events (REDUCE) study. Men were divided in 2 groups based on testosterone level < or ≥300 ng/dL. Diagnostic properties of total serum PSA, free-PSA ratio, and PSA density to predict PCa and csPCa, defined as Gleason score ≥7, were determined for several thresholds and plotted as receiver operator characteristic curves. A total of 603 men (18.3%) had low testosterone. The prevalence of PCa and csPCa was 92 (15.3%) and 27 (4.5%), respectively, for low testosterone men compared to 458 (17.0%) and 138 (5.1%), correspondingly, for normal testosterone men. Total PSA, free-PSA ratio and PSA density showed similar sensitivity, specificity, and accuracy to predict PCa and csPCa among low testosterone men compared to normal testosterone men. Among subjects in a clinical trial with a prior negative biopsy, total PSA, free-PSA ratio and PSA density have comparable diagnostic characteristics for PCa screening in low and normal testosterone men.