Testosterone treatment linked with prostate cancer

Clinically apparent prostate cancer developed within months to a few years after initiation of testosterone supplementation in 20 men from 6 different urology practices, according to a report in the August issue of The Journal of Urology.

“There is a paucity of data regarding the risks of testosterone replacement, as there have been no well controlled randomized prospective studies performed to carefully look at the risk of prostate cancer developing in men treated with testosterone,” Dr. Franklin D. Gaylis from University of California at San Diego Medical Center, told Reuters Health.”There are several anecdotal case reports, small studies, and observational studies like ours which raise concern but do not provide conclusive evidence yet,” he said.Dr. Gaylis and colleagues reported this series of patients “in whom clinically significant prostate cancer developed and was presumed to be related to exogenous testosterone use.”Prostate cancer was detected within 2 years of the start of testosterone replacement in 11 of these men, 7 of them within the first year, the authors report. The others were diagnosed 28 months to 8 years after initiation of testosterone supplementation.Eleven men had normal digital rectal examinations before testosterone supplementation was begun, the report indicates, and the median PSA level of the 17 men tested before treatment was 3.1 ng/mL (range, 0.9 to 15.0 ng/mL).At cancer detection, the researchers note, digital rectal examination was abnormal in 15 men, and PSA was normal in 6 men.”It is our belief that men, especially those with a family history of prostate cancer, should not receive a prescription for testosterone supplementation without careful, informed consultation regarding the risks and benefits of such treatment,” the investigators conclude. “Furthermore, testosterone should not be prescribed for any man until a serum PSA assay and digital rectal examination have been performed and a close follow-up plan is formulated and accepted by the patient.””I would hope that guidelines would be developed by experts in the field to help us appropriately and carefully prescribe testosterone replacement to men who clearly need it and who would benefit from it, and then monitor them for potential adverse outcomes, e.g., the development of prostate cancer,” Dr. Gaylis said.”Despite the serious flaws in this study,” writes Dr. E. Darracott Vaughan, Jr. from Weill Medical College of Cornell University, New York in a related editorial, “the article can be taken as a ‘shot across the bow’ for urologists and other physicians. We need to be extremely careful before beginning testosterone therapy.””Testosterone therapy should not be initiated in patients with a family history of prostate cancer, an increased PSA, or an abnormal digital rectal examination without a negative prostatic biopsy,” Dr. Vaughan concludes.(Source: J Urol 2005;174:534-538: Reuters Health: Will Boggs, MD: Oncolink: August 2005.)