JAMA internal medicine · 2026
Testosterone Treatment in Prostate Cancer Survivors With Hypogonadism: A Randomized Clinical Trial.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Bhasin Shalender, Burnett Arthur L, Gagliano-Jucá Thiago, Storer Thomas W, Reid Kieran F, Shang Yili Valentine, Privat Fabiola, Chandra Mohan S, Weiss Mary, Memish-Beleva Yusnie, Lam Helen, Kibel Adam S, Pencina Karol M
Аннотация
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 included sexual desire, erectile function, well-being, body composition, aerobic capacity, and physical function. The safety outcome was biochemical recurrence (PSA ≥ 0.2 ng/mL).
RESULTS: A total of 136 men were randomized, 68 to receive testosterone cypionate, 100 mg, and 68 to receive placebo, and 125 men completed the study. Groups were similar at baseline (mean [SD] age, 68.6 [6.5] years; 52 [38%] had a Gleason score of 6; and 84 [62%] had a Gleason score of 7). No participant in either group experienced biochemical recurrence. TRT significantly increased sexual activity more than placebo, adjusted for PDE5I use and age (between-group difference, 0.91 daily events [95% CI, 0.56-1.26]; P < .001). TRT increased sexual desire and prostate cancer quality-of-life sexual domain score, and decreased negative affect more than placebo. Erectile function did not change. TRT significantly improved body composition, loaded stair-climbing power, and peak aerobic performance (VO2 peak) compared with placebo.
CONCLUSIONS AND RELEVANCE: 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. The trial was neither long enough nor large enough to evaluate clinical recurrence or long-term safety; this proof-of-concept trial was essential for rationalizing a larger, long-term study. These findings do not apply to men with high-grade prostate cancer or those treated with androgen deprivation therapy or radiation therapy.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03716739.
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 included sexual desire, erectile function, well-being, body composition, aerobic capacity, and physical function. The safety outcome was biochemical recurrence (PSA ≥ 0.2 ng/mL).
RESULTS: A total of 136 men were randomized, 68 to receive testosterone cypionate, 100 mg, and 68 to receive placebo, and 125 men completed the study. Groups were similar at baseline (mean [SD] age, 68.6 [6.5] years; 52 [38%] had a Gleason score of 6; and 84 [62%] had a Gleason score of 7). No participant in either group experienced biochemical recurrence. TRT significantly increased sexual activity more than placebo, adjusted for PDE5I use and age (between-group difference, 0.91 daily events [95% CI, 0.56-1.26]; P < .001). TRT increased sexual desire and prostate cancer quality-of-life sexual domain score, and decreased negative affect more than placebo. Erectile function did not change. TRT significantly improved body composition, loaded stair-climbing power, and peak aerobic performance (VO2 peak) compared with placebo.
CONCLUSIONS AND RELEVANCE: 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. The trial was neither long enough nor large enough to evaluate clinical recurrence or long-term safety; this proof-of-concept trial was essential for rationalizing a larger, long-term study. These findings do not apply to men with high-grade prostate cancer or those treated with androgen deprivation therapy or radiation therapy.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03716739.