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December 10, 2014
Testosterone Therapy: No Increased Prostate Cancer Risk In Hypogonadal Men 

Bremerhaven, Germany—Testosterone (T) therapy does not increase the risk of prostate cancer in hypogonadal men according to a German review of three parallel, prospective, ongoing, cumulative registry studies of more than 1,000 patients.

The report was published recently in The Journal of Urology.

“Although considerable evidence exists indicating no relationship between testosterone and increased risk of developing PCa [prostate cancer], decades of physician training with the notion that testosterone is fuel for PCa made it difficult to dispel such fallacy and the myth continued to persist,” said lead investigator Ahmad Haider, MD, PhD, a urologist, in Bremerhaven. “Nevertheless, in the absence of long-term follow-up data demonstrating reduced risk of PCa in hypogonadal men who are receiving T therapy, considerable skepticism remains throughout the medical community and this is an expected natural and acceptable path of medical and scientific discourse. In view of the current evidence, clinicians are compelled to think this over and cannot justify withholding T therapy in hypogonadal men, also in men who have been successfully treated for PCa.”

In the study cohort, 1,023 patients on testosterone therapy were followed for up to 17 years with a median follow-up of about 5 years. Two study cohorts of 261 (cohort 1) and 340 (cohort 2) men had been treated by urologists since 2004 with a third cohort of 422 men treated at an academic andrology center since 1996.

A diagnosis of hypogonadism was made if testosterone levels were ≤12 nmol/L and if other symptoms were present, such as erectile dysfunction, fatigue, depression, or unfavorable changes in body composition, including gaining of fat mass and waist circumference despite physical activity. If no contraindications were present, T therapy was initiated in all patients.

Results indicated six (2.3%) diagnoses of PCa in cohort 1, five (1.5%) in cohort 2, with all biopsies negative in cohort 3.

Prostate incidence per 10,000 patient-years in cohorts 1 and 2 was 54.4 and 30.7, respectively; that was lower than the 116 reported by the PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) and the 96.6 reported by the ERSPC (European Randomized Study of Screening for Prostate Cancer), study authors point out.

“Testosterone therapy in hypogonadal men does not increase the risk of prostate cancer,” the study concludes. “If guidelines for testosterone therapy are properly applied, testosterone treatment is safe in hypogonadal men.”

A research letter published last year in JAMA Internal Medicine looked at more than 10 million men age 40 and over, finding that use of testosterone therapy increased more than threefold, from 0.81% percent in 2001 to 2.91% in 2011 in men over 40.  By 2011, 2.29% of men in their 40s and 3.75% of men in their 60s were taking some form of testosterone therapy, according to that study.



U.S. Pharmacist Social Connect