TY - JOUR
T1 - Testosterone replacement in prostate cancer survivors with testosterone deficiency
T2 - Study protocol of a randomized controlled trial
AU - Valderrábano, Rodrigo J.
AU - Pencina, Karol
AU - Storer, Thomas W.
AU - Reid, Kieran F.
AU - Kibel, Adam S.
AU - Burnett, Arthur L.
AU - Huang, Grace
AU - Dorff, Tanya
AU - Privat, Fabiola
AU - Ghattas-Puylara, Catherine
AU - Wilson, Lauren
AU - Latham, Nancy K.
AU - Holmberg, Mats
AU - Bhasin, Shalender
N1 - Funding Information:
We thank Amy Larson for her stalwart regulatory and institutional support. We thank Drs. Adrian Dobbs, Walter Ambrosius, and Rahul Aggarwal for serving as the Data and Safety Monitoring Board members. The SPIRIT Trial is supported by National Institutes on Aging grant number 1RO1AG06539‐01. This research is partially supported by the infrastructural resources provided by the Boston Claude D. Pepper Older Americans Independence Center at BWH (P30AG013679) and Harvard Catalyst | The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic healthcare centers.
Funding Information:
Dr. Bhasin reports receiving research grants from the National Institute on Aging, the National Institute of Nursing Research, National Center for Medical Rehabilitation Research of the National Institute of Child Health and Human Development, Patient‐Centered Outcomes Research Institute, AbbVie, and Metro International Biotech, and consulting fees from OPKO and Aditum Bio. These grants are managed by the BWH and overseen by the Office of Industry Interaction of the Mass General Brigham.
Publisher Copyright:
© 2022 American Society of Andrology and European Academy of Andrology.
PY - 2023/1
Y1 - 2023/1
N2 - Background: 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. Objectives: 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. Methods: Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone 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 prostate specific antigen 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 prostate-specific antigen, lower urinary tract symptoms, hemoglobin, and adverse events. Results: The trial is being conducted at two trial sites in Boston, MA and Baltimore, MD. As of July 30, 2022, 42 participants have been randomized. No prostate-specific antigen or clinical recurrence has been noted to-date. Discussion: Recruitment was slowed by coronavirus disease 2019-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. Conclusion: The Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone 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.
AB - Background: 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. Objectives: 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. Methods: Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone 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 prostate specific antigen 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 prostate-specific antigen, lower urinary tract symptoms, hemoglobin, and adverse events. Results: The trial is being conducted at two trial sites in Boston, MA and Baltimore, MD. As of July 30, 2022, 42 participants have been randomized. No prostate-specific antigen or clinical recurrence has been noted to-date. Discussion: Recruitment was slowed by coronavirus disease 2019-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. Conclusion: The Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone 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.
KW - hypogonadism
KW - prostate cancer
KW - prostatectomy
KW - testosterone treatment
UR - http://www.scopus.com/inward/record.url?scp=85139782773&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85139782773&partnerID=8YFLogxK
U2 - 10.1111/andr.13299
DO - 10.1111/andr.13299
M3 - Article
C2 - 36181480
AN - SCOPUS:85139782773
SN - 2047-2919
VL - 11
SP - 93
EP - 102
JO - Andrology
JF - Andrology
IS - 1
ER -