Testosterone therapy to improve recovery after major urologic surgery in men with low testosterone
Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study
This study is testing if giving testosterone therapy to men with low testosterone can help them recover better after major urologic surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT04731376 on ClinicalTrials.gov |
What this trial studies
This phase I trial evaluates the safety and feasibility of administering testosterone replacement therapy to hypogonadal male patients undergoing major urologic surgery. Participants are divided into two groups: one receiving testosterone cypionate injections weekly for three months, and the other receiving standard care. The study aims to assess improvements in post-operative outcomes such as hospital stay duration, complications, and overall quality of life. The findings may influence future treatment protocols regarding testosterone testing and replacement in surgical settings.
Who should consider this trial
Good fit: Ideal candidates include hypogonadal men scheduled for major surgery requiring an overnight hospital stay.
Not a fit: Patients with a history of prostate cancer treatment or those currently on hormone replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and reduce complications for patients with low testosterone undergoing major surgery.
How similar studies have performed: While testosterone therapy has shown benefits in other contexts, this specific perioperative approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Kenneth Ogan, MD — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Kenneth Ogan, MD
- Email: kogan@emory.edu
- Phone: 404-778-3038
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.