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

New York, NY, November 25, 2014

Testosterone(T) therapy is routinely used in men with hypogonadism, a condition in whichdiminished function of the gonads occurs. Although there is no evidence that Ttherapy increases the risk of prostate cancer (PCa), there are still concernsand a paucity of long-term data. In a new study in The Journal of Urology®, investigators examined threeparallel, prospective, ongoing, cumulative registry studies of over 1,000 men.Their analysis showed that long-term T therapy in hypogonadal men is safe anddoes not increase the risk of PCa.

Leadinvestigator Ahmad Haider, MD, PhD, urologist, Bremerhaven, Germany, states,"Although considerable evidence exists indicating no relationship betweentestosterone and increased risk of developing PCa, decades of physiciantraining with the notion that testosterone is fuel for PCa made it difficult todispel such fallacy and the myth continued to persist. Nevertheless, in theabsence of long-term follow-up data demonstrating reduced risk of PCa inhypogonadal men who are receiving T therapy, considerable skepticism remainsthroughout the medical community and this is an expected natural and acceptablepath of medical and scientific discourse. In view of the current evidence,clinicians are compelled to think this over and cannot justify withholding Ttherapy in hypogonadal men, also in men who have been successfully treated forPCa."

Atotal of 1,023 patients on T therapy were followed for up to 17 years with amedian 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 cohortof 422 men was treated at an academic andrology center since 1996. Hypogonadismwas diagnosed if testosterone was ≤12 nmol/L and if other symptoms werepresent, such as erectile dysfunction, fatigue, depression, or unfavorablechanges in body composition (gaining of fat mass and waist circumferencedespite physical activity). If no contraindications were present, all werestarted on T therapy.

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

Investigatorsstress that if guidelines for T therapy are properly applied, it is safe inhypogonadal men.

---

Notes for editors
"Incidenceof Prostate Cancer in Hypogonadal Men Receiving Testosterone Therapy:Observations from Five Year-median Follow-up of Three Registries," by AhmadHaider, Michael Zitzmann, Gheorghe Doros, Hendrik Isbarn, Peter Hammerer, andAksam 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 credentialedjournalists upon request; contact Linda Gruner at +1 212 633 3923 or jumedia@elsevier.com to obtaincopies. Journalists wishing to interview the authors may contact Prof. AksamYassin 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 toits readership all the clinically relevant information needed to stay at theforefront of this dynamic field. This top-ranking journal presentsinvestigative studies on critical areas of research and practice, surveyarticles providing short condensations of the best and most important urologyliterature worldwide and practice-oriented reports on interesting clinicalobservations.

About Elsevier
Elsevier is a global information analytics company that helps institutions and professionals progress science, advance healthcare and improve performance for the benefit of humanity. Elsevier provides digital solutions and tools in the areas of strategic research management, R&D performance, clinical decision support, and professional education; including ScienceDirect, Scopus, ClinicalKey and Sherpath. Elsevier publishes over 2,500 digitized journals, including The Lancet and Cell, more than 35,000 e-book titles and many iconic reference works, including Gray's Anatomy. Elsevier is part of RELX Group, a world-leading provider of information and analytics to professionals and business customers, in a wide range of industries. www.elsevier.com

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