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NCT Number: NCT04731376

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

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.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gonadal Disorders Male Urogenital Diseases Malignant Urinary System Neoplasm Neoplasms Neoplasms by Site Urinary System Disorder Urinary System Neoplasm Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive standard peri-operative care

Other names: standard of care, standard therapy

quality-of-life assessment

Procedure

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively

Testosterone Cypionate

Drug

Given IM

Other names: depAndro, Depo-Testosterone, Depotest, Depovirin, Pertestis, Virilon

Primary outcomes

  1. Changes in quality of life before and after surgery

    Time frame: Baseline to 3 months

    The Patient Reported Outcomes Measurement Information System (PROMIS Global Health-10) is a 10 question survey that uses questions concerning physical function, overall quality of life, physical health, mood, ability to participate in social roles and activities, pain and fatigue to arrive at a score between 10 and 50. Patient's score are the outcome we will measure.

  2. Change in frailty phenotype before and after surgery

    Time frame: 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.

    The Fried Frailty Criteria uses a comorbidity scale, measures of activity, physical tests of strength and speed, nutritional status and anatomic features to produce a score from 0-5. These numbers correspond with the following frailty categorizations: non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5). This score represents one outcome measure.

  3. Major complications

    Time frame: Within 90 days of surgery

    Major complication considered Clavien-Dindo IIIb and above.

  4. Minor complications

    Time frame: Within 90 days of surgery

    Minor complication considered Clavien-Dindo IIIb and below.

  5. Rate of intensive care unit (ICU) admission

    Time frame: Up to 3 months post-surgery

    Admissions to the ICU between post-op day 1 to 90 days post surgery

  6. Hospital length of stay

    Time frame: Up to 3 months post-operative

    Number of days stayed in the hospital after surgery

  7. Discharge disposition

    Time frame: Discharge from hospital

    Determined by if patient is discharged to home, to home with services, or to facility.

  8. Unplanned readmissions

    Time frame: Within 90 days of surgery

    Readmissions to hospital after discharge within 90 days

  9. Mortality rate

    Time frame: Within 90 days of surgery

    Rate of patient deaths after surgery

  10. Testosterone level

    Time frame: Up to 3 months post-operative

    Levels of Testosterone determined by laboratory blood draw

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Feb 1, 2021
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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