No Prostate Cancer Risk With Testosterone for Hypogonadism

Liam Davenport

December 10, 2014

The risk for prostate cancer is not increased in hypogonadal men treated with testosterone therapy, thereby dispelling a long-held myth among doctors, the results of a long-term registry-based study indicate.

The study, by Ahmad Haider (Centre for Reproductive Medicine and Andrology, University Clinics Muenster, Germany) and colleagues, is published in the January issue of the Journal of Urology.

The researchers note that despite considerable evidence that there is no relationship between testosterone and increased risk of developing prostate cancer, "decades of physician training" have left many doctors "with the notion that testosterone is fuel for prostate cancer."

The new findings, which revealed a low incidence of prostate cancer in over 1000 men given testosterone therapy for a median of 5 years, should reassure clinicians and patients alike that such treatment can be used safely, they say.

Indeed, the European Association of Urology (EAU) guidelines on male hypogonadism suggest that even men who have been treated surgically for localized prostate cancer and who are currently without any evidence of active disease and meet the diagnosis of hypogonadism can be cautiously considered candidates for testosterone therapy, they point out.

Similar recommendations were noted in the International Society for the Study of the Aging Male, International Society for Sexual Medicine, and Endocrine Society guidelines, they add.

Asked to comment on the findings, Farid Saad, PhD (Bayer, Berlin, Germany), whose organization provided statistical support to the researchers, said the results are "robust" and provide "relatively long-term data," where prior studies using testosterone and addressing this question have been small and short.

"The number of patients who were diagnosed with prostate cancer over the time was lower than expected, if we base our expectations on what was published in previous studies," he told Medscape Medical News.

Nevertheless, he said the findings cannot be considered completely conclusive. "A definitive study would require…at least 6000 patients in a placebo-controlled setting, followed up for at least 5 years."

But this study shows "what the pharmacovigilance people say is 'no signal' for an increase in risk and...so I think this is confirmation of what the guidelines say."

Up to 17 Years of Testosterone Therapy in Three Observational Cohorts

Dr Haider and colleagues point out the lack of any large, long-term prospective studies on the impact of testosterone therapy on prostate cancer risk. For this reason, they decided to examine the incidence of this carcinoma from three parallel, prospective registry studies in which a total of 1023 hypogonadal men were treated with testosterone therapy for up to 17 years.

One cohort consisted of 261 men with an average age of 60 years who presented with erectile dysfunction, another comprised 340 men with a mean age of 57 who presented with a number of conditions, and the third contained 422 men, average age of 41 years, who presented with symptoms of hypogonadism.

Across all three cohorts, the baseline prostate-specific antigen level was less than 4 ng/mL. Patients were treated when total testosterone levels were 12.1 nmol/L (350 ng/dL) or less and hypogonadism symptoms were present.

All patients received testosterone undecanoate 1000-mg injections at 12-week intervals, continued for 75 months in the first cohort, 87 months in the second, and 17 years in the third.

The incidence of prostate cancer was 2.6% in the first cohort, giving an estimated incidence per 10,000 patient-years of 54.4. In the second cohort, the incidence was 1.5%, and the estimated incidence per 10,000 patient-years was 30.70. No prostate cancer cases were reported in the third cohort — a younger patient population.

The overall incidence of prostate cancer was 11 cases (1.08%), which is lower than the incidence rates reported previously in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial and in the European Randomized Study of Screening for Prostate Cancer.

"In view of the current evidence, clinicians are compelled to think this over and cannot justify withholding testosterone therapy in hypogonadal men, [including] men who have been successfully treated for prostate cancer," Dr Haider and colleagues conclude.

And Dr Saad said that, crucially, the registries are ongoing. "New patients are entered into the study all the time. The data are updated once a year, and there are no selection criteria for the patients other than they have hypogonadism."

The patients within the registries are also extremely mixed, he observed, and present with a number of comorbidities. For example, approximately one-third of the patients have type 2 diabetes, so it will be possible to perform subgroup analyses on the data.

"This is just something that will reassure doctors who are interested in testosterone treatment that…there are a number of studies suggesting the same thing: there is not an increased risk."

Dr Haider has a financial interest in and/or other relationship with Jenapharm, Bayer, Takeda, and Astellas. Disclosures for the authors are listed in the article. Dr Saad is an employee of Bayer.

J Urol. 2015;193:80-86. Abstract

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