Prostate-Specific Antigen Levels During Testosterone Treatment of Hypogonadal Older Men: Data from a Controlled Trial
Year: 2019
Type: article
Abstract: CONTEXT: Prostate-specific antigen (PSA) changes during testosterone treatment of older hypogonadal men have not been rigorously evaluated. DESIGN: Double-blinded, placebo-controlled trial. SETTING: Twelve US academic medical centers. PARTICIPANTS: 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. INTERVENTIONS: Testosterone or placebo gel for 12 months. MAIN OUTCOMES: Percentile changes in PSA during testosterone treatment of 12 months. RESULTS: 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. CONCLUSIONS: 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.
Authors: Glenn R Cunningham, Susan S Ellenberg, Shalender Bhasin, Alvin M Matsumoto, J Kellogg Parsons, Peter Preston, Jane A Cauley, Thomas M Gill, Ronald S Swerdloff, Christina Wang, Kristine E Ensrud, Cora E Lewis, Marco Pahor, Jill P Crandall, Mark E Molitch, Denise Cifelli, Shehzad Basaria, Susan J Diem, Alisa J Stephens-Shields, Xiaoling Hou, Peter J Snyder
Institutions: Baylor College of Medicine, University of Pennsylvania, Brigham and Women's Hospital, Harvard University, University of Washington, VA Puget Sound Health Care System, University of California San Diego, University of Pittsburgh, Yale University, University of California, Los Angeles, The Lundquist Institute, Los Angeles Medical Center, Harbor–UCLA Medical Center, University of Minnesota, Minneapolis VA Health Care System, University of Alabama at Birmingham, University of Florida, Albert Einstein College of Medicine, Northwestern University
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: National Institutes of Health, National Institute on Aging, National Institute of Diabetes and Digestive and Kidney Diseases, National Center for Advancing Translational Sciences, Claude D. Pepper Older Americans Independence Center, University of California San Francisco, Yale Center for Clinical Investigation, Yale School of Medicine
Awards: Testerone Trial, The Bone Trial of the Testosterone Trial, Research Training in Disability & Disabling Disorders, G2780457950, G4222196665, ACADEMIC LEADERSHIP AWARD IN DISABILITY AND DISABLING DISORDERS, UAB Diabetes Research and Training Center, G6345280176, Clinical and Translational Science Award, Yale University Clinical and Translational Science Award Program, G828869042, University of Florida Older Americans Independence Center (OAIC), Yale Clinical and Translational Science Award, UAB Diabetes Research Center, Claude D. Pepper Older Americans Independence Center at Yale
OpenAlex ID: W2963045108