Long-Term Testosterone Therapy Does Not Increase the Risk of Prostate Cancer

New study in the Journal of Urology® analyzed results from three independent registries
Nov 26, 2014 9:00 AM ET

New York, NY, November 25, 2014 /3BL Media/ – Testosterone (T) therapy is routinely used in men with hypogonadism, a condition in which diminished function of the gonads occurs. Although there is no evidence that T therapy increases the risk of prostate cancer (PCa), there are still concerns and a paucity of long-term data. In a new study in The Journal of Urology®, investigators examined three parallel, prospective, ongoing, cumulative registry studies of over 1,000 men. Their analysis showed that long-term T therapy in hypogonadal men is safe and does not increase the risk of PCa.

Lead investigator Ahmad Haider, MD, PhD, urologist, Bremerhaven, Germany, states, “Although considerable evidence exists indicating no relationship between testosterone and increased risk of developing PCa, 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. 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.”

A total of 1,023 patients on T therapy were followed for up to 17 years with a median follow-up of approximately 5 years. Two study cohorts of 261 (cohort 1) and 340 (cohort 2) men were treated by urologists since 2004 and a third cohort of 422 men was treated at an academic andrology center since 1996. Hypogonadism was diagnosed if testosterone was ≤12 nmol/L and if other symptoms were present, such as erectile dysfunction, fatigue, depression, or unfavorable changes in body composition (gaining of fat mass and waist circumference despite physical activity). If no contraindications were present, all were started on T therapy.

There were six (2.3%) diagnoses of PCa in cohort 1, there were five (1.5%) diagnoses of PCa in cohort 2, and all biopsies were negative in cohort 3. PCa incidence per 10,000 patient-years in cohorts 1 and 2 was 54.4 and 30.7, respectively, which is lower than 116 reported by the PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) and 96.6 reported by the ERSPC ( European Randomized Study of Screening for Prostate Cancer). 

Investigators stress that if guidelines for T therapy are properly applied, it is safe in hypogonadal men.

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Notes for editors
“Incidence of Prostate Cancer in Hypogonadal Men Receiving Testosterone Therapy: Observations from Five Year-median Follow-up of Three Registries,” by Ahmad Haider, Michael Zitzmann, Gheorghe Doros, Hendrik Isbarn, Peter Hammerer, and Aksam Yassin. DOI: http://dx.doi.org/10.1016/j.juro.2014.06.071. The Journal of Urology®, Volume 193/Issue 1 (January 2015) by Elsevier.

Full text of this article is available to credentialed journalists upon request; contact Linda Gruner at +1 212 633 3923 or jumedia@elsevier.com to obtain copies. Journalists wishing to interview the authors may contact Prof. Aksam Yassin at yassin@t-online.de or Dr. Farid Saad, Global Medical Affairs, Bayer Pharma AG, at farid.saad@bayer.com.

About the Journal of Urology®
Established in 1917, The Journal of Urology® (www.jurology.com) is the official journal of the American Urological Association (www.auanet.org). It is the most widely read and highly cited journal in the field. It brings to its readership all the clinically relevant information needed to stay at the forefront of this dynamic field. This top-ranking journal presents investigative studies on critical areas of research and practice, survey articles providing short condensations of the best and most important urology literature worldwide and practice-oriented reports on interesting clinical observations.

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Media contact
Linda Gruner
Elsevier
+1 212 633 3923
jumedia@elsevier.com