1. In a population of men with hypogonadism and PSA concentrations less than 3 ng/mL, patients randomized to receive testosterone replacement therapy (TRT) did not have an associated increased incidence of prostate cancer compared with the placebo.
Evidence Rating Level: 1 (Excellent)
The association between TRT and prostate cancer risk is not fully understood. The Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) study aims to compare the effects of TRT and placebo on the incidences of prostate cancer, acute urinary retention, invasive prostate surgical procedures for BPH, and initiation of pharmacologic therapy for BPH. The study included 5204 patients (mean [SD] age, 63.3 [7.9] years; mean (SD) follow-up duration, 33.0 (12.1) months) with 1 or more symptoms of hypogonadism and a PSA level of less than 3 ng/mL. Subjects were randomly assigned in a 1:1 ratio to either receive a 1.62% transdermal testosterone gel or a placebo gel. During 14 304 person-years of follow-up, there was no significant difference in the incidence of high-grade prostate cancer between groups (5 of 2596 [0.19%] in the TRT group vs 3 of 2602 [0.12%] in the placebo group; hazard ratio, 1.62; 95% CI, 0.39-6.77; P = .51). The rate of any prostate cancer did not differ between the placebo and TRT groups (HR, 1.07; 95% CI, 0.47-2.42; P = .87). The incidence of acute urinary retention, invasive prostate surgical procedures, and new pharmacologic treatment for lower urinary tract symptoms did not differ significantly between groups. Compared with the placebo group, the TRT group exhibited significantly greater increases in PSA levels at 3, 12, 24, 36, and 48 months irrespective of baseline PSA (P < .001), but there was no significant between-group difference in PSA levels after month 12. The findings of the study suggest that TRT in men with hypogonadism was associated with a low risk of adverse prostate events, including cancer.
Click to read the study in JAMA Network Open
Image: PD
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