Testosterone replacement in prostate cancer survivors with testosterone deficiency: Study protocol of a randomized controlled trial.

Most men diagnosed with prostate cancer today have organ-confined disease and low risk of disease recurrence after radical prostatectomy. Testosterone deficiency in prostate cancer survivors contributes to impaired health-related quality of life but testosterone treatment is viewed as a contraindication in this population.

We describe the design of the first randomized trial to determine the safety and efficacy of testosterone treatment in men who have undergone prostatectomy for non-aggressive prostate cancer and have symptomatic testosterone deficiency.

Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone Trial (The SPIRIT Trial) is a randomized, placebo-controlled, double-blind, parallel group trial in 142 men, ≥40 years, who have undergone radical prostatectomy for organ-confined prostate cancer, Gleason score ≤7 (3+4), Stage pT2, N0, M0 lesions and have symptomatic testosterone deficiency and undetectable PSA for >2 years after surgery. Eligible participants are randomized to weekly intramuscular injections of 100-mg testosterone cypionate or placebo for 12 weeks and followed for another 12 weeks. Primary endpoint is change from baseline in sexual activity. Secondary outcomes include change in sexual desire, erectile function, energy, lean and fat mass, physical and cognitive performance. Safety is assessed by monitoring PSA, lower urinary tract symptoms, hemoglobin, and adverse events.

The trial is being conducted at 2 trial sites in Boston, MA and Baltimore, MD. As of July 30, 2022, 42 participants have been randomized. No PSA or clinical recurrence has been noted to-date.

Recruitment was slowed by COVID-19-related closures, slow subsequent ramp-up of research activities, and patient concerns about safety of testosterone treatment. Despite these challenges, participant retention has been high.

The SPIRIT Trial, a placebo-controlled, randomized trial, will determine whether testosterone replacement therapy is safe and efficacious in correcting symptoms of testosterone deficiency in prostate cancer survivors, and potentially inform clinical practice. This article is protected by copyright. All rights reserved.

Andrology. 2022 Oct 01 [Epub ahead of print]

Rodrigo J Valderrábano, Karol Pencina, Thomas W Storer, Kieran F Reid, Adam S Kibel, Arthur L Burnett, Grace Huang, Tanya Dorff, Fabiola Privat, Catherine Ghattas-Puylara, Lauren Wilson, Nancy K Latham, Mats Holmberg, Shalender Bhasin

Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Department of Urology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, CA, USA., ANOVA, Karolinska University Hospital, Stockholm, Sweden.

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