Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer

Completed

• Conditions: Bladder Cancer; Low Testosterone Levels

• Registration Number: NCT03063125
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Study Start: 2017-03-31
• Primary Completion: 2018-04-20
• Study Completion: 2018-04-20
• Results First Submitted: 2020-09-08
• Results First Submitted QC: 2021-04-14
• Results First Posted: 2021-05-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• Diagnosis of bladder cancer
• Scheduled to undergo radical cystectomy

Exclusion Criteria

• Evidence of advanced metastatic disease,
• Undergoing cystectomy for non-bladder primary malignancy or bladder cancer type other than urothelial cell
• History of breast or prostate cancer
• Polycythemia, cardiovascular thromboembolism, untreated obstructive sleep apnea, uncontrolled heart failure, or acute coronary event in the past six months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Hypogonadism in Participants Based on Serum Testosterone 90 Days Post Radical	90 days post-RC surgery	The count of participants with hypogonadism (the level of serum testosterone used as a threshold).

Secondary Outcome Measures

Name	Time	Method
The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy	30 days post-RC surgery	The count of participants with hypogonadism 30 days post radical cystectomy using the serum testosterone levels (the level of serum testosterone used as a threshold).
The Number of Hypogonadism in Participants Based on Serum Testosterone Immediately Post Surgery Days Post Radical Cystectomy	Immediately post-operatively RC surgery	The count of participants with hypogonadism immediately post radical cystectomy based on levels of testosterone (the level of serum testosterone used as a threshold).
The Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy	Baseline, prior to RC surgery	The count of participants with hypogonadism at baseline days post radical cystectomy (the level of serum testosterone used as a threshold).

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States