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

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ClinicalTrials.gov Identifier: NCT04731376
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University

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.

Condition or disease Intervention/treatment Phase
Hypogonadism Malignant Urinary System Neoplasm Urinary System Disorder Urinary System Neoplasm Other: Best Practice Procedure: Quality-of-Life Assessment Other: Questionnaire Administration Drug: Testosterone Cypionate Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Perioperative Testosterone Replacement Therapy Improves Outcomes: A Pilot Safety and Feasibility Study
Actual Study Start Date : January 25, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Drug: Testosterone Cypionate
Given IM
Other Names:
  • depAndro
  • Depo-Testosterone
  • Depotest
  • Depovirin
  • Pertestis
  • Virilon

Active Comparator: Arm II (best practice)
Patients with normal testosterone levels receive standard peri-operative care.
Other: Best Practice
Receive standard peri-operative care
Other Names:
  • standard of care
  • standard therapy

Procedure: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 who are undergoing chemotherapy and/or radiation therapy pre- or post-operatively
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04731376


Contacts
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Contact: Kenneth Ogan, MD 404-778-3038 kogan@emory.edu

Locations
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United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mersiha Torlak    404-778-4823    mersiha.torlak@emory.edu   
Principal Investigator: Kenneth Ogan, MD         
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Kenneth Ogan, MD Emory University Hospital/Winship Cancer Institute
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Responsible Party: Kenneth Ogan, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04731376    
Other Study ID Numbers: STUDY00001062
NCI-2020-06998 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EU5097-20 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
P30CA138292 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Urologic Neoplasms
Urologic Diseases
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Urogenital Neoplasms
Neoplasms by Site
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents