Abstract
Objective
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.
Methods
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.
Results
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.
Conclusion
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.
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Article info
Publication history
Published online: November 13, 2019
Accepted:
November 4,
2019
Received:
July 26,
2019
Footnotes
Funding: None.
Identification
Copyright
© 2019 Elsevier Inc. All rights reserved.
