Prostate
Post-RP survivorship: placebo-controlled TRT data in low-grade (Gleason ≤3+4) hypogonadal men, excluding RT-treated pts.
TRT in Prostate Cancer Survivors (Bhasin RCT) NCT03716739
ForLow-grade (GG1-2) PCa post-RP, PSA undetectable ≥2y, symptomatic hypogonadism
0.91 daily events
95% CI 0.56-1.26, P<.001
TL;DRSexual activity +0.91 daily events vs placebo (95% CI 0.56-1.26, P<.001) with 12wk testosterone; zero biochemical recurrences in low-grade post-RP hypogonadal men.
RT-treated men were excluded by design, and the authors state the findings do not apply to them; this trial gives no safety data for TRT after definitive RT or ADT. For the post-RT survivor asking about testosterone, the evidence gap is unchanged, and the zero-BCR result in undetectable-PSA post-RP men does not transfer.
In a Gleason 3+3 or 3+4 post-prostatectomy man with PSA undetectable for ≥2 years and symptomatic low testosterone, this supports discussing short-term TRT; it does not extend to high-grade disease or men treated with RT or ADT.
Randomized, blinded data now counter the blanket contraindication for low-grade post-RP survivors, with zero BCR over 12 weeks. That window cannot assess slower androgen-driven recurrence, and the authors exclude ADT-treated and high-grade disease, so any survivorship TRT discussion stays limited to that narrow group.
The enrolled population is the urologic post-prostatectomy follow-up clinic: Gleason ≤3+4, organ-confined, PSA undetectable ≥2y. Libido, energy and body composition improved over 12 weeks, but erectile function did not, so post-RP erectile complaints still need their own pathway.
9 details
Randomized, placebo-controlled, double-blind phase 2 at 2 academic centers; concealed block randomization stratified by age (40-60 vs >60y) and PDE5I use. Enrollment May 2019 to last visit May 2025.
Men ≥40y with organ-confined Gleason 6 or 7 (3+4) PCa, undetectable PSA ≥2y after RP, mean testosterone <275 ng/dL, plus low libido, ED, or fatigue. Mean age 68.6; 38% Gleason 6, 62% Gleason 7.
Testosterone cypionate 100 mg IM weekly for 12 weeks vs placebo.
Primary: sexual activity. Secondary: sexual desire, erectile function, well-being, body composition, aerobic capacity, physical function. Safety: biochemical recurrence (PSA ≥0.2 ng/mL).
Sexual activity rose by 0.91 daily events (95% CI 0.56-1.26, P<.001). Desire, QoL sexual domain, negative affect, body composition, stair-climb power and VO2 peak improved; erectile function did not change.
No biochemical recurrence in either arm over 12 weeks; 125 of 136 completed.
Guidelines treat prior PCa as a TRT contraindication, citing absence of randomized safety and efficacy data; this is randomized, blinded evidence in that population, though only for short-term exposure.
Erectile function, often the complaint driving the TRT request, did not move. Single dose and 2 academic sites; generalizability to other formulations and community practice untested.
Efficacy is established for the short term; the open question is oncologic safety, which zero BCR events in 12 weeks cannot settle. The authors position this as the rationale for a larger long-term trial.
CONSORT flow
Clean randomized double-blind design hits efficacy EP, but 12wk exposure and N=136 leave the oncologic safety question (BCR) unpowered; authors call it proof-of-concept.
- Long-term clinical recurrence risk with prolonged TRT
- Safety of TRT after definitive RT or ADT
- Applicability to high-grade prostate cancer survivors