Clinical trial NCT04731376: Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone
Official title: Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hypogonadism
Malignant Urinary System Neoplasm
Urinary System Disorder
Urinary System Neoplasm
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-02-01
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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) for 3 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients with normal testosterone levels receive standard peri-operative care.

Eligibility criteria: Inclusion Criteria:

* Patients already scheduled for major surgery requiring an overnight hospital stay
* Patients must be able to give informed consent
* Patients must be willing to do study's preoperative and post-operative assessment tools

Exclusion Criteria:

* Patient with history of prostatectomy with detectable prostate specific antigen (PSA)
* Patient with history of prostate radiation/chemotherapy treatment and has experienced bounce or rise in PSA
* Patients with history of/undergoing orchiectomy
* Patients undergoing hormone replacement therapy currently or history of testosterone use within last year
* Patients who use anabolic steroids
* Patients with history of solitary or undescended testis
* Patients with history of pituitary disorders
* Patients with history of thromboembolic events in last year
* Patients with hematocrit \> 55%
* Patients with uncontrolled congestive heart failure
* Special populations: Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women and prisoners

Primary outcomes:
measure: Changes in quality of life before and after surgery
timeFrame: Baseline to 3 months
measure: Change in frailty phenotype before and after surgery
timeFrame: Baseline, post operative refers to the period after the procedure until final follow up and study completion. Will occur an average of 90 days after the procedure.
measure: Major complications
timeFrame: Within 90 days of surgery
measure: Minor complications
timeFrame: Within 90 days of surgery
measure: Rate of intensive care unit (ICU) admission
timeFrame: Up to 3 months post-surgery
measure: Hospital length of stay
timeFrame: Up to 3 months post-operative
measure: Discharge disposition
timeFrame: Discharge from hospital
measure: Unplanned readmissions
timeFrame: Within 90 days of surgery
measure: Mortality rate
timeFrame: Within 90 days of surgery
measure: Testosterone level
timeFrame: Up to 3 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Kenneth Ogan, MD
role: PRINCIPAL_INVESTIGATOR
References: