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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (testosterone cypionate) | Experimental | Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months. |
|
| Arm II (best practice) | Active Comparator | Patients with normal testosterone levels receive standard peri-operative care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard peri-operative care |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Ogan, MD | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2024 |
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| Quality-of-Life Assessment | Procedure | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies; Quality of life questionnaires will be given both preoperatively and at 3-months postoperatively |
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| Testosterone Cypionate | Drug | Given IM |
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| 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 |
| Apr 16, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 16, 2025 | Apr 16, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D014571 | Urologic Neoplasms |
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| C016131 | testosterone 17 beta-cypionate |
| D043343 | Testosterone Propionate |
| D008777 | Methyltestosterone |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D013739 | Testosterone |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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