Testosterone replacement therapy may not increase risk of prostate cancer among men with hypogonadism

Men with hypogonadism and no high risk for prostate cancer who received TRT showed low and similar incidences of high-grade or any prostate cancer, acute urinary retention, and invasive surgical procedures for BPH compared to a placebo. TRT did not worsen lower urinary tract symptoms, according to a recent study published in JAMA Network Open.

The study conducted in 316 clinical trials in the US aimed to compare the effect of TRT versus placebo. The primary outcome measured was the incidence of adjudicated high-grade prostate cancer, and secondary endpoints included the incidence of any adjudicated prostate cancer, acute urinary retention, invasive prostate surgical procedure, prostate biopsy, and new pharmacologic treatment. The intervention effect was analyzed using a discrete-time proportional hazards model.

Key points from the study are:

• The study included 5198 men of mean age 63 years with hypogonadism with increased risk or preexisting cardiovascular disease.
• 2596 men received TRT.
• 1.62 % testosterone transdermal gel was applied daily during the study period.
• 2602 patients in the placebo group were given matching placebo gel to be applied daily.
• At baseline, the mean PSA concentration and IPSS were 0.92 ng/mL and 7.1, respectively.
• The mean treatment duration in the TRT group and placebo was 21.8 months and 21.6 months, respectively.
• During 14 304 person-years of follow-up, the incidence of high-grade prostate cancer did not differ significantly between groups. (0.19 % for TRT and o.12 % for placebo with a hazard ratio of 1.62)
• There was a greater increase in PSA concentrations in testosterone-treated men.

The study's findings will help clinicians and patients make informed decisions about the potential risks of TRT, they said.

Reference:

Bhasin S et al. Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Netw Open. 2023;6(12):e2348692. doi:10.1001/jamanetworkopen.2023.48692