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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypogonadism, Malignant Urinary System Neoplasm, Urinary System Disorder, Urinary System Neoplasm

Intervention / Treatment
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* Other: Best Practice
* Procedure: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Drug: Testosterone Cypionate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |