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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2021
  • participants needed
    100
  • sponsor
    Emory University
Updated on 1 March 2021

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.

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.

Details
Condition URINARY TRACT DISORDER, urinary tract neoplasm, Hypogonadism, Urologic Cancer, uropathy, urinary tract cancer, urinary tract disorders, urinary tract disease, urological disease, urological diseases
Treatment questionnaire administration, quality-of-life assessment, Best Practice, Testosterone cypionate
Clinical Study IdentifierNCT04731376
SponsorEmory University
Last Modified on1 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: urinary tract disease or urinary tract cancer or urological disease or Hypogonadism or urological diseases or URINARY TRACT DISORDER or urinary tract ...?
Do you have any of these conditions: urinary tract disorders or urological diseases or Urologic Cancer or urinary tract cancer or urinary tract neoplasm or URINARY TRACT DISORDER or uropa...?
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 who are undergoing chemotherapy and/or radiation therapy pre- or post-operatively
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
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