Testosterone Treatment in Prostate Cancer Survivors With Hypogonadism: A Randomized Clinical Trial
An erratum to this article was published (JAMA Intern Med, 1 Jul 2026 ↗)
Primary result · Sexual activityResult — go to the resultBetween-group difference 0.91 daily events 95% CI 0.56–1.26Authors' conclusion
In this randomized clinical trial, TRT for 12 weeks in men treated with radical prostatectomy for low-grade prostate cancer significantly improved sexual activity, sexual desire, well-being, body composition, physical function, and aerobic performance compared to placebo without biochemical recurrence.
Study context
- Population
- Men ≥40 years with organ-confined, low-grade prostate cancer (Gleason 6 [3 + 3] or 7 [3 + 4]), undetectable prostate-specific antigen (PSA) ≥2 years after radical prostatectomy, mean of 2 testosterone levels <275 ng/dL, and low libido, erectile dysfunction or fatigue; mean (SD) age 68.6 (6.5) years125 completed
- Participants
- 136 men
- Comparison
- Testosterone cypionate 100 mg IM weekly vs placebo for 12 weeks
- Testosterone cypionaten = 68
- Placebon = 68reference
- Primary endpoint
- Sexual activity
- Follow-up
- 12 weeks
Methodological detailsplacebo-controlled, double-blind, parallel-group, phase 2, 2 academic medical centres, concealed block randomisation stratified for age and PDE5I use, First participant randomised May 13, 2019; last study visit completed May 16, 2025
- Placebo-controlled
- Double-blind
- Parallel-group
- Phase 2
- 2 academic medical centres
- Concealed block randomisation stratified for age and PDE5I use
- First participant randomised May 13, 2019; last study visit completed May 16, 2025
Primary result
As reported in the abstract
Between-group difference
0.91 daily events
95% CI 0.56–1.26
P < 0.001
Testosterone cypionatevs Placebo
between-group difference 0.91 daily events (95% CI 0.56–1.26); P < 0.001
Secondary outcomes
Sexual desire, prostate cancer QoL sexual domain score and negative affect
- Testosterone replacement therapy (TRT) increased sexual desire and prostate cancer quality-of-life sexual domain score, and decreased negative affect more than placebo
Erectile function
- Erectile function did not change
Body composition, physical function and aerobic capacity
- TRT significantly improved body composition, loaded stair-climbing power, and peak aerobic performance (VO2 peak) vs placebo
Safety
Events
| Outcome | Testosterone cypionate | Placebo |
|---|---|---|
| Biochemical recurrence (PSA ≥ 0.2 ng/mL) | 0 | 0 |
Original publication
Testosterone Treatment in Prostate Cancer Survivors With Hypogonadism: A Randomized Clinical Trial. JAMA Intern Med. Published 1 July 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →