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

Emory University

Status and phase: Enrolling; Phase 1

Conditions: Urinary System Neoplasm; Hypogonadism; Urinary System Disorder; Malignant Urinary System Neoplasm

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04731376

P30CA138292 (U.S. NIH Grant/Contract)

NCI-2020-06998 (Registry Identifier)

STUDY00001062

EU5097-20 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm I (testosterone cypionate)

Experimental group

Description:

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

Treatment:

Drug: Testosterone Cypionate

Other: Questionnaire Administration

Procedure: Quality-of-Life Assessment

Arm II (best practice)

Active Comparator group

Description:

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

Treatment:

Other: Best Practice

Other: Questionnaire Administration

Procedure: Quality-of-Life Assessment