RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study

Quick Facts

Study Start:2021-01-25
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04731376

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients already scheduled for major surgery requiring an overnight hospital stay
  2. * Patients must be able to give informed consent
  3. * Patients must be willing to do study's preoperative and post-operative assessment tools
  1. * Patient with history of prostatectomy with detectable prostate specific antigen (PSA)
  2. * Patient with history of prostate radiation/chemotherapy treatment and has experienced bounce or rise in PSA
  3. * Patients with history of/undergoing orchiectomy
  4. * Patients undergoing hormone replacement therapy currently or history of testosterone use within last year
  5. * Patients who use anabolic steroids
  6. * Patients with history of solitary or undescended testis
  7. * Patients with history of pituitary disorders
  8. * Patients with history of thromboembolic events in last year
  9. * Patients with hematocrit \> 55%
  10. * Patients with uncontrolled congestive heart failure
  11. * Special populations: Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women and prisoners

Contacts and Locations

Study Contact

Kenneth Ogan, MD
CONTACT
404-778-3038
kogan@emory.edu

Principal Investigator

Kenneth Ogan, MD
PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute

Study Locations (Sites)

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Kenneth Ogan, MD, PRINCIPAL_INVESTIGATOR, Emory University Hospital/Winship Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-25
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-01-25
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Hypogonadism
  • Malignant Urinary System Neoplasm
  • Urinary System Disorder
  • Urinary System Neoplasm