Long-term TRT study refutes concerns about prostate safety

A study of more than 300 men sheds new light on the prostate safety of testosterone replacement therapy.

New Orleans-Data from a single center’s growing cohort of hypogonadal men provide additional evidence supporting the prostate safety of testosterone replacement therapy (TRT).

READ: Injected TRT earns high marks for safety, effectiveness

Dr. HaiderAt the AUA annual meeting, Ahmad Haider, MD, PhD, presented outcomes from analyses of data collected for 347 men who are part of a longitudinal observational registry study being conducted in his private practice in Bremerhaven, Germany.

All patients had a testosterone level ≤350 ng/dL at entry. They had a mean age of 57 years and were started on testosterone undecanoate (TU [AVEED]), 1,000 mg injections given every 12 weeks after 2 loading doses at 0 and 6 weeks.

Maximum follow-up has now reached 87 months, 67 men had reached the 84-month visit, and the total follow-up for the cohort is 1,806 person-years.

During the available follow-up, prostate cancer was diagnosed in six men (1.7%). Time to diagnosis was 10 to 19 months after TRT initiation, the diagnosis in all men was made following an increase in PSA, and maximum Gleason score was 3+3.

All patients underwent radical prostatectomy. Pathologic T stage was pT2a in four men, pT2b in one, and pT1b in one. TRT was temporarily interrupted, but resumed by five of the six men, Dr. Haider reported.

SEE: Studies examine risk factors for low, high T

“The incidence of prostate cancer in our population was calculated as 27.7 per 10,000 patient years, which is far below the incidence reported in large screening studies,” he said, citing the Prostate, Lung, Colorectal, and Ovarian Cancer screening trial and the European Randomized Study of Screening for Prostate Cancer.

NEXT: 'A paradigm shift'

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Dr. TraishAbdulmaged M. Traish, MBA, PhD, professor of urology and biochemistry at Boston University School of Medicine, was a co-author of the paper. Speaking to Urology Times, he said, “Androgen deprivation therapy has been used in the management of prostate cancer for more than 7 decades based on the concept that testosterone causes prostate cancer development and progression. During that time, there is no evidence that quality of life or survival has improved with ADT,” Dr. Traish said.

“Now it is time to have a paradigm shift in our view of the relationship between testosterone and prostate cancer. Clearly, there is no credible scientific or clinical evidence that links testosterone to development or progression of prostate cancer. The time has come to train the new generation of clinicians and scientists in the light of the new paradigm and leave the old myth behind.”

Aside from the patient with prostate cancer who did not go back on TRT, all of the hypogonadal men who started on TRT are continuing with their TU injections. At the time the analyses were performed, 209 men had been on treatment for 2 years, 122 were seen after 4 years, and 82 had reached the 5-year follow-up.

Other results showed mean PSA for the entire cohort increased slightly over time (+0.09 ng/mL). The change was not statistically significant. Mean prostate volume increased, but by only 2.46 mL, which is not clinically important, Dr. Haider said.

NEXT: No evidence TRT negatively affected voiding function

Analyses of International Prostate Symptom Score and postvoid residual bladder volume showed no evidence that TRT negatively affected voiding function. Mean International Prostate Symptom Score was around 6.5 at baseline and decreased progressively (improved) and significantly over the entire observation time. Postvoid residual bladder volume decreased significantly in parallel to IPSS, with a mean decrease of 34.17 mL.

C-reactive protein is also being measured during follow-up and showed a steady and statistically significant decrease over time. At 84 months, the mean change from baseline was -5.83 mg/dL.

Dr. Haider commented that some of the benefits occurring among the men being treated with TRT may be the result of anti-inflammatory effects of TRT and weight loss, which was also observed in the cohort.