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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypogonadism; Malignant Urinary System Neoplasm; Urinary System Disorder; Urinary System Neoplasm
• Intervention / Treatment: Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Testosterone Cypionate; Other: Best Practice

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (testosterone cypionate); Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months.	Procedure: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively; Drug: Testosterone Cypionate; Given IM; Other Names: Depo-Testosterone; depAndro; Depotest; Depovirin; Pertestis; Virilon
Active Comparator: Arm II (best practice); Patients with normal testosterone levels receive standard peri-operative care.	Procedure: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively; Other: Best Practice; Receive standard peri-operative care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kenneth Ogan, MD, Emory University Hospital/Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): November 26, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gonadal Disorders; Urologic Diseases; Hypogonadism; Urologic Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Polycyclic Compounds; Quality Indicators, Health Care; Steroids; Fused-Ring Compounds; Gonadal Steroid Hormones; Gonadal Hormones; Androstenes; Androstanes; Guidelines as Topic; Quality Assurance, Health Care; Androstenols; Testosterone Congeners; Testosterone; Methyltestosterone; testosterone 17 beta-cypionate; Standard of Care; Practice Guidelines as Topic; Testosterone Propionate
• Other Study ID Numbers: STUDY00001062; P30CA138292 (U.S. NIH Grant/Contract); NCI-2020-06998 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); EU5097-20 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No