Glenn R Cunningham1, Susan S Ellenberg2, Shalender Bhasin3, Alvin M Matsumoto4,5, J Kellogg Parsons6, Peter Preston2, Jane A Cauley7, Thomas M Gill8, Ronald S Swerdloff9,10, Christina Wang9,10, Kristine E Ensrud11,12, Cora E Lewis13, Marco Pahor14, Jill P Crandall15, Mark E Molitch16, Denise Cifelli17, Shehzad Basaria3, Susan J Diem11,12, Alisa J Stephens-Shields2, Xiaoling Hou17, Peter J Snyder18. 1. Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine, Baylor St. Luke's Medical Center, Houston, Texas. 2. Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 3. Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. 4. Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs Puget Sound Health Care System, Seattle, Washington. 5. Division of Gerontology & Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine, Seattle, Washington. 6. Department of Urology, Moores Comprehensive Cancer Center, University of California San Diego, San Diego, California. 7. Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania. 8. Division of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut. 9. Division of Endocrinology, Harbor-University of California at Los Angeles Medical Center, Torrance, California. 10. Los Angeles Biomedical Research Institute, Torrance, California. 11. Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, Minnesota. 12. Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota. 13. Department of Epidemiology, School of Public Health at UAB, Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama. 14. Department of Aging & Geriatric Research, University of Florida, Gainesville, Florida. 15. Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, New York. 16. Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University, Feinberg School of Medicine, Chicago, Illinois. 17. Center for Clinical Epidemiology & Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 18. Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
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.
RCT Entities:
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.
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