T therapy safe in large prostate Ca series

San Francisco-It appears to be safe for clinicians to consider testosterone therapy for symptomatic men with testosterone deficiency and a history of prostate cancer, according to new data presented at the AUA annual meeting in San Francisco.

In the largest series to date, investigators found that prostate cancer recurrence rates were consistent with previously published recurrence/progression rates for the various forms of treatment for localized prostate cancer and for men on active surveillance.

Lead study author Abraham Morgentaler, MD, associate clinical professor of urology at Harvard Medical School, Beth Deaconess Medical Center, Boston, said these new findings provide valuable and reassuring information for clinicians and patients with symptomatic testosterone deficiency and a history of prostate cancer.

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“There is growing evidence that [testosterone therapy] is not as risky as we once thought, and I think it is time to consider offering it to a larger population of men with prostate cancer who are symptomatic from testosterone deficiency,” Dr. Morgentaler said in an interview with Urology Times.

When he and his co-authors looked at men with prostate cancer who were on active surveillance or had received radiation or radical prostatectomy, there were no significant differences in recurrence rates or progression rates in men who received testosterone therapy, Dr. Morgentaler reported. However, the authors noted some of the data are still rather preliminary. Among 190 men, the progression rate (higher Gleason score) in men on testosterone was 10.6% in 47 men on active surveillance with >4 years mean follow-up and there were no recurrences in five mentreated with radical prostatectomy followed by salvage radiation, with a mean follow up of >2 years.

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‘Reasonable evidence’ for T in symptomatic men

Dr. Morgentaler said these reassuring results now provide justification for liberalizing the use of testosterone therapy in men with prostate cancer.

“Testosterone therapy has been contraindicated for decades in men with prostate cancer on the basis of weak, circumstantial evidence. This series, the largest to date, provides reasonable evidence that supports its use in symptomatic men,” said Dr. Morgentaler.

The researchers mined electronic medical record databases at a large single center to identify men who received therapy for testosterone deficiency after diagnosis and/or treatment of prostate cancer over the previous 5 years. In this cohort, testosterone was delivered via transdermal gels/liquids, short- and long-acting injections, and/or pellets.

There is a limited body of evidence regarding the safety of testosterone therapy in men with a history of prostate cancer, and the authors noted that it continues to be a controversial issue in clinical practice. The team identified 320 men with a diagnosis of both prostate cancer and testosterone deficiency and 222 men received testosterone therapy. The authors excluded 32 men because they had <3 months follow-up or were diagnosed with advanced disease.

A total of 190 men remained in the study and their mean age was 68 years (range, 41-88 years). The mean follow-up was 47.0 months. Among the 190 men, 86 underwent prostatectomy, 49 received radiotherapy, three men underwent high-intensity focused ultrasound (HIFU), and 47 were on active surveillance. The study showed that biochemical recurrences occurred in 10 men after prostatectomy (11.6%), in two men after radiation therapy (4.1%), and in two men after HIFU. Among the men on active surveillance, progression occurred in five men (10.6%).

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John Roger Bell, MD, assistant professor of urology at the University of Kentucky, Lexington, said patients with a history of testosterone deficiency after a diagnosis of prostate cancer continue to pose a challenge for clinicians and that these findings are good news.

“This study provides a solid foundation for this question. However, the study is derived from a database and does not present the risk stratification of the patients analyzed. There is also no control arm, and the follow-up is limited at a mean of 47 months,” Dr. Bell told Urology Times.

He said further study utilizing a control arm and performing a subgroup analysis using prostate cancer risk stratification may clarify these data and help elucidate which patients may benefit the most from testosterone therapy.

Dr. Morgentaler is a consultant for Acerus and Aytu BioScience, and has a research grant from Endo Pharmaceuticals. One of his co-authors is a consultant/adviser for Aytu BioScience and Eli Lilly.