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- Title
Prostate-Specific Antigen Levels During Testosterone Treatment of Hypogonadal Older Men: Data from a Controlled Trial.
- Authors
Cunningham, Glenn R; Ellenberg, Susan S; Bhasin, Shalender; Matsumoto, Alvin M; Parsons, J Kellogg; Preston, Peter; Cauley, Jane A; Gill, Thomas M; Swerdloff, Ronald S; Wang, Christina; Ensrud, Kristine E; Lewis, Cora E; Pahor, Marco; Crandall, Jill P; Molitch, Mark E; Cifelli, Denise; Basaria, Shehzad; Diem, Susan J; Stephens-Shields, Alisa J; Hou, Xiaoling
- Abstract
<bold>Context: </bold>Prostate-specific antigen (PSA) changes during testosterone treatment of older hypogonadal men have not been rigorously evaluated.<bold>Design: </bold>Double-blinded, placebo-controlled trial.<bold>Setting: </bold>Twelve US academic medical centers.<bold>Participants: </bold>Seven hundred ninety hypogonadal men ≥65 years of age with average testosterone levels ≤275 ng/dL. Men at high risk for prostate cancer were excluded.<bold>Interventions: </bold>Testosterone or placebo gel for 12 months.<bold>Main Outcomes: </bold>Percentile changes in PSA during testosterone treatment of 12 months.<bold>Results: </bold>Testosterone treatment that increased testosterone levels from 232 ± 63 ng/dL to midnormal was associated with a small but substantially greater increase (P < 0.001) in PSA levels than placebo treatment. Serum PSA levels increased from 1.14 ± 0.86 ng/mL (mean ± SD) at baseline by 0.47 ± 1.1 ng/mL at 12 months in the testosterone group and from 1.25 ± 0.86 ng/mL by 0.06 ± 0.72 ng/mL in the placebo group. Five percent of men treated with testosterone had an increase ≥1.7 ng/mL and 2.5% of men had an increase of ≥3.4 ng/mL. A confirmed absolute PSA >4.0 ng/mL at 12 months was observed in 1.9% of men in the testosterone group and 0.3% in the placebo group. Four men were diagnosed with prostate cancer; two were Gleason 8.<bold>Conclusions: </bold>When hypogonadal older men with normal baseline PSA are treated with testosterone, 5% had an increase in PSA ≥1.7 ng/mL, and 2.5% had an increase ≥3.4 ng/mL.
- Subjects
GLEASON grading system; TESTOSTERONE; OLDER men; MEDICAL center design &; construction; PROSTATE; ANTIGENS; ACADEMIC medical centers; PROSTATE cancer
- Publication
Journal of Clinical Endocrinology & Metabolism, 2019, pN.PAG
- ISSN
0021-972X
- Publication type
journal article
- DOI
10.1210/jc.2019-00806