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J Urol. 2015 Jan;193(1):80-6. doi: 10.1016/j.juro.2014.06.071. Epub 2014 Jun 26.

Incidence of prostate cancer in hypogonadal men receiving testosterone therapy: observations from 5-year median followup of 3 registries.

Author information

  • 1Bremerhaven, Germany.
  • 2Centre for Reproductive Medicine and Andrology / Clinical Andrology, University Clinics Muenster, Münster, Germany.
  • 3Department of Epidemiology and Statistics, Boston University School of Public Health, Boston, Massachusetts.
  • 4Department of Urology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
  • 5Department of Urology and Uro-Oncology, Klinikum Braunschweig, Braunschweig, Germany.
  • 6Institute of Urology and Andrology, Segeberger Kliniken, Norderstedt, Germany; Dresden International University, Dresden, Germany; Department of Urology, Gulf Medical University, Ajman, United Arab Emirates.

Abstract

PURPOSE:

Although there is no evidence that testosterone therapy increases the risk of prostate cancer, there is a paucity of long-term data. We determined whether the incidence of prostate cancer is increased in hypogonadal men receiving long-term testosterone therapy.

MATERIALS AND METHODS:

In 3 parallel, prospective, ongoing, cumulative registry studies 1,023 hypogonadal men received testosterone therapy. Two study cohorts were treated by urologists (since 2004) and 1 was treated at an academic andrology center (since 1996). Patients were treated when total testosterone was 12.1 nmol/l or less (350 ng/dl) and symptoms of hypogonadism were present. Maximum followup was 17 years (1996 to 2013) and median followup was 5 years. Mean baseline patient age in the urological settings was 58 years and in the andrology setting it was 41 years. Patients received testosterone undecanoate injections in 12-week intervals. Pretreatment examination of the prostate and monitoring during treatment were performed. Prostate biopsies were performed according to EAU guidelines.

RESULTS:

Numbers of positive and negative biopsies were assessed. The incidence of prostate cancer and post-prostatectomy outcomes was studied. A total of 11 patients were diagnosed with prostate cancer in the 2 urology settings at proportions of 2.3% and 1.5%, respectively. The incidence per 10,000 patient-years was 54.4 and 30.7, respectively. No prostate cancer was reported by the andrology center. Limitations are inherent in the registry design without a control group.

CONCLUSIONS:

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

Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

KEYWORDS:

hypogonadism; incidence; prostatic neoplasms; testosterone; testosterone undecanoate

PMID:
24980615
[PubMed - indexed for MEDLINE]
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