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

NCT04731376 | Active Not Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: STUDY00001062NCI-2020-06998EU5097-20P30CA138292
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism; Urinary System Disorder; Urinary System Neoplasm; Malignant Urinary System Neoplasm

Outcome Measures

Primary Outcomes (10)

• Changes in quality of life before and after surgery

  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.

  Baseline to 3 months

• Change in frailty phenotype before and after surgery

  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.

  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.

• Major complications

  Major complication considered Clavien-Dindo IIIb and above.

  Within 90 days of surgery

• Minor complications

  Minor complication considered Clavien-Dindo IIIb and below.

  Within 90 days of surgery

• Rate of intensive care unit (ICU) admission

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

  Up to 3 months post-surgery

• Hospital length of stay

  Number of days stayed in the hospital after surgery

  Up to 3 months post-operative

• Discharge disposition

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

  Discharge from hospital

• Unplanned readmissions

  Readmissions to hospital after discharge within 90 days

  Within 90 days of surgery

• Mortality rate

  Rate of patient deaths after surgery

  Within 90 days of surgery

• Testosterone level

  Levels of Testosterone determined by laboratory blood draw

  Up to 3 months post-operative

Study Arms (2)

Arm I (testosterone cypionate)

EXPERIMENTAL

Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months.

Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Testosterone Cypionate

Arm II (best practice)

ACTIVE COMPARATOR

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

Other: Best Practice; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard peri-operative care

Also known as: standard of care, standard therapy

Arm II (best practice)

Quality-of-Life Assessment PROCEDURE

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (testosterone cypionate); Arm II (best practice)

Questionnaire Administration OTHER

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

Arm I (testosterone cypionate); Arm II (best practice)

Testosterone Cypionate DRUG

Given IM

Also known as: depAndro, Depo-Testosterone, Depotest, Depovirin, Pertestis, Virilon

Arm I (testosterone cypionate)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Hypogonadism; Urologic Neoplasms; Urologic Diseases

Interventions

Practice Guidelines as Topic; Standard of Care; testosterone 17 beta-cypionate; Testosterone Propionate; Methyltestosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Kenneth Ogan, MD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: February 1, 2021
• Study Start: January 25, 2021
• Primary Completion: November 26, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (1)