Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients with Low Testosterone

Active:	Yes
Cancer Type:	Unknown Primary	NCT ID:	NCT04731376
Trial Phases:	Phase I	Protocol IDs:	EU5097-20 (primary) NCI-2020-06998
Eligibility:	18 Years and older, Male	Study Type:	Supportive care
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04731376

Summary

This phase I trial investigates the safety of testosterone replacement therapy around the time of major urologic surgery (perioperative) in order to improve quality of life and post-operative outcomes such as decreased length of hospital stay, complications, and mortality in patients with low testosterone levels. Studies have demonstrated that patients undergoing testosterone replacement therapy have increased lean body mass, decreased fat mass and have improved physical function. Testosterone replacement therapy can also stimulate bone formation and may decrease the risk of fracture. Information from this trial may be used to support the incorporation of testosterone level testing and testosterone replacement into the perioperative treatment decision-making process.

Objectives

PRIMARY OBJECTIVE:
I. To examine the safety and feasibility of perioperative testosterone replacement (TR) therapy in hypogonadal male patients undergoing major operations.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients with low testosterone levels receive testosterone cypionate intramuscularly (IM) once a week (QW) or topically once daily (QD) for 3 months in the absence of disease progression or unacceptable toxicity. Patients may also undergo a digital rectal examination (DRE) as clinically indicated.

ARM II: Patients with normal testosterone levels receive standard peri-operative care. Patients may also undergo a DRE as clinically indicated.

After completion of study treatment, patients are followed up at 90 days.

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