A PHASE 2 randomised clinical trial suggests that short-term testosterone replacement therapy (TRT) may safely improve sexual and physical function in carefully selected prostate cancer survivors with hypogonadism.
The double-blind, placebo-controlled study enrolled 136 men aged 40 years and older who had previously undergone radical prostatectomy for organ-confined, low-grade prostate cancer. Eligible participants had maintained undetectable prostate-specific antigen (PSA) levels for at least two years after surgery and had symptomatic hypogonadism, defined by testosterone concentrations below 275 ng/dL alongside symptoms such as low libido, erectile dysfunction, or fatigue.
Testosterone Therapy Improved Sexual Activity and Desire
Participants were randomised to receive either weekly intramuscular testosterone cypionate 100 mg or placebo for 12 weeks. The investigators reported significant improvements in sexual activity in the TRT group compared with placebo, with an adjusted between-group difference of 0.91 daily sexual events. Sexual desire and prostate cancer-specific sexual quality-of-life scores also improved significantly, while negative affect decreased.
Importantly for urologists, no biochemical recurrences were observed during treatment or the subsequent three-month follow-up period. Biochemical recurrence was defined as a PSA level of at least 0.2 ng/mL.
Beyond sexual outcomes, TRT was associated with favourable changes in body composition, loaded stair-climbing power, and peak aerobic capacity (VO2 peak), suggesting broader functional benefits in this patient population. However, erectile function itself did not significantly improve during the study period.
The authors noted that concerns regarding testosterone use after prostate cancer treatment have historically limited access to TRT in hypogonadal survivors, despite many men with low-grade disease having excellent long-term prognoses following radical prostatectomy. Current clinical guidelines often still regard prior prostate cancer as a contraindication because of limited randomised safety data.
Larger Studies Needed to Assess Long-Term Safety
Researchers cautioned that the trial was not designed to assess long-term oncological safety or clinical recurrence risk. They emphasised that the findings apply only to men with low-grade disease treated surgically and should not be extrapolated to patients with high-grade cancer, prior radiation therapy, or androgen deprivation therapy.
The researchers concluded that the findings provide proof of concept for larger and longer-duration studies evaluating TRT safety in prostate cancer survivors.
Reference
Bhasin S et al. Testosterone treatment in prostate cancer survivors with hypogonadism: a randomized clinical trial. JAMA Intern Med. 2026; DOI: 10.1001/jamainternmed.2026.1343.
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