Testosterone safety and the prostate

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1 Testosterone safety and the prostate Professor Dr. Ridwan Shabsigh Director, Division of Urology, Maimonides Medical Center, Brooklyn, NY, Professor of Clinical Urology, College of Physicians and Surgeons, Columbia University, New York

2 Risks in context Rhoden & Morgentaler NEJM 2004

3 Concerns lead to under-treatment around the world 100% % of physicians who rate the respective reason against TT as very important 80% 71% 66% 60% 52% 50% Brazil Saudi Arabia South Korea Germany Spain UK 42% 40% 24% 20% 16% 17% 18% 18% 12% 12% 10% 12% 11% 4% 2% 6% 6% 3% 0% Assumed risk of prostate cancer Gooren, Behre et al. Aging Male 2007 Patient expresses concerns regarding testosterone therapy Assumed BPH risk Budgetary reasons

4 The prostate enemy? An ongoing debate around the link between testosterone therapy and prostate complications However, androgens such as testosterone are necessary for the development and normal function of the prostate: - cellular - differentiation - proliferation - metabolism - secretory function

5 Normal healthy man prostate volume 19 ml PSA 0.9 ng/ml Untreated hypogonadal man prostate volume 8 ml PSA 0.4 ng/ml

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7 maximal urine flow (ml/s) Effect on uroflow 40 Uroflow in untreated hypogonadal men (n=47), testosterone-treated hypogonadal men (n=78), and age-matched normal men (n=75) untreated hypogonadal men T-treated hypogonadal men normal men Behre et al. Clin Endocrinol 1994

8 Effect on PSA levels 4 upper normal limit PSA in untreated hypogonadal men (n=47), testosterone-treated hypogonadal men (n=78), and age-matched normal men (n=75) PSA (ng/ml) Increase of serum PSA: 0.4 ng/ml 0 untreated hypogonadal men testosterone-treated hypogonadal men normal men Behre et al. Clin Endocrinol 1994

9 Epidemiology of prostate cancer Ruijter et al. Endocr Rev 1999

10 Prospective studies support safety of testosterone therapy A Collaborative Analysis of 18 Prospective Studies on Endogenous Sex Hormones and Prostate Cancer JNCI 2008

11 Prospective studies support safety of testosterone therapy A Collaborative Analysis of 18 Prospective Studies on Endogenous Sex Hormones and Prostate Cancer JNCI 2008

12 Meta-analysis supports safety of testosterone therapy in older men 19 RCT (651 men were treated with testosterone and 433 with placebo) Prostate 1.90 ( ) CVS 0.94 ( ) Hematocrit 5.07 ( ) Calof et al. J Gerontol 2005

13 Meta-analysis supports safety of testosterone therapy in older men Pooled odds rations for adverse events in primary analysis Event Testosterone group: adverse event rate per 1000 patient years Placebo group: adverse event rate per 1000 patient years Pooled odds ratio 95% confidence interval Prostate biopsies , 4.15 Prostate cancers , 2.49 PSA >4ng/ml or 1.5 ng/ml increase during study , 2.09 Increase IPSS score , 2.52 Acute urinary retention , 2.44 All prostate events , RCT (651 men were treated with testosterone and 433 with placebo) Calof et al. J Gerontol 2005

14 Sponsor: New England Research Institutes, Inc., USA (Raymond C. Rosen, PhD, RHYME Principal Investigator) Founding Grantor: Bayer Schering Pharma AG, Germany

15 Registry objectives Primary objective To examine association between testosterone therapy, prostate cancer and other prostate health outcomes in men with hypogonadism Secondary objectives To assess routinely-monitored symptoms/general health outcomes associated with testosterone therapy To examine natural history of HG in men To assess clinical course of HG in men undergoing testosterone therapy

16 Registry overview Registry of men with diagnosed HG Treatment decisions rest with patient and physician Conducted according to Standard Of Care (SOC) 4 visits over 2 yrs (baseline, 3-6 m, 12 m, 24 m) Data capture: SOC measurements N = 1,000 from 20 Clinical Sites in the EU Risks and benefits of testosterone therapy treatment can be evaluated in the context of a real world registry

17

18 Conclusions Widespread concern regarding the safety of testosterone therapy in relation to the prostate Safety concerns are leading to under-treatment of testosterone deficiency There is no evidence that testosterone therapy increases the risk of prostate cancer Testosterone therapy is contra-indicated in the presence of prostate cancer

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