Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial
Primary result · High-grade prostate cancerResult — go to the resultHazard ratio 1.62 95% CI 0.39–6.77Authors' conclusion
In a population of middle-aged and older men with hypogonadism, carefully evaluated to exclude those at high risk of prostate cancer, the incidences of high-grade or any prostate cancer and other prostate events were low and did not differ significantly between testosterone- and placebo-treated men. The study's findings may facilitate a more informed appraisal of the potential risks of TRT.
Study context
- Population
- Men aged 45–80 years with hypogonadism (2 testosterone concentrations <300 ng/dL, hypogonadal symptoms) and cardiovascular disease (CVD) or increased CVD risk, 316 US sites; Prostate-specific antigen (PSA) >3.0 ng/mL and International Prostate Symptom Score (IPSS) >19 excluded5,204 analysed
- Participants
- 5,246 men
- Comparison
- Topical 1.62% testosterone gel vs placebo
- Testosterone replacement therapy (TRT)n = 2,596
- Placebon = 2,602reference
- Primary endpoint
- Incidence of adjudicated high-grade prostate cancer (Gleason score ≥4 + 3)
Methodological detailsplacebo-controlled, double-blind, multicentre, stratified for prior CVD, Analysed with a discrete-time proportional hazards model, Enrollment May 23, 2018, to February 1, 2022; end-of-study visits May 31, 2022, to January 19, 2023
- Placebo-controlled
- Double-blind
- Multicentre
- Stratified for prior CVD
- Analysed with a discrete-time proportional hazards model
- Enrollment May 23, 2018, to February 1, 2022; end-of-study visits May 31, 2022, to January 19, 2023
Primary result
High-grade prostate cancer · 14 304 person-years of follow-up
Hazard ratio
1.62
95% CI 0.39–6.77
P = 0.51
Events by treatment group
As reported in the abstract
Secondary outcomes
Treatment duration
Any prostate cancer, acute urinary retention, invasive surgical procedures, prostate biopsy, new pharmacologic treatment
- Incidences did not differ significantly between groups
Change in IPSS
- Change in IPSS did not differ between groups
PSA concentration
- PSA increased more with TRT than placebo
Safety
| Outcome | TRT | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| High-grade prostate cancer (primary prostate safety end point) | 0.19% | 0.12% | 1.62 (0.39–6.77) | P = 0.51 | |
| 0.10.31310Hazard ratio (log scale) |
Original publication
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