Testosterone Treatment in Prostate Cancer Survivors With Hypogonadism: A Randomized Clinical Trial
Abstract
IMPORTANCE: A majority of men with prostate cancer have low-grade cancer and an excellent prognosis after radical prostatectomy. Hypogonadism and associated symptoms impair quality of life in prostate cancer survivors. Many guidelines, citing a lack of randomized clinical trials showing safety and efficacy of testosterone replacement therapy (TRT), consider a history of prostate cancer a contraindication for TRT.
OBJECTIVE: To evaluate the short-term safety and efficacy of TRT in prostate cancer survivors with symptomatic hypogonadism.
DESIGN, SETTING, AND PARTICIPANTS: This randomized, placebo-controlled, double-blind, parallel-group, phase 2 trial was conducted at 2 academic medical centers in men 40 years and older with organ-confined, low-grade prostate cancer (Gleason score of 6 [3 + 3] or 7 [3 + 4]). Participants had undetectable prostate-specific antigen (PSA) for at least 2 years after radical prostatectomy, a mean of 2 testosterone levels less than 275 ng/dL, and low libido, erectile dysfunction, or fatigue. Patients were allocated using concealed, block randomization, with stratification for age (40-60 years or >60 years) and phosphodiesterase-5 inhibitor (PDE5I) use. The first participant was randomized on May 13, 2019, and the last study visit was completed on May 16, 2025.
INTERVENTION: Testosterone cypionate, 100 mg, or placebo intramuscularly weekly for 12 weeks.
MAIN OUTCOMES AND MEASURES: The primary efficacy outcome was sexual activity. Secondary outcomes…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 136 participants or records.
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