Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063125
• Other study ID #: STUDY00140348
• Status: Completed
• Start date: March 31, 2017
• Est. completion date: April 20, 2018

Study information

• Verified date: July 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 20, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Hypogonadism
• Low Testosterone Levels
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Hypogonadism in Participants Based on Serum Testosterone 90 Days Post Radical	The count of participants with hypogonadism (the level of serum testosterone used as a threshold).	90 days post-RC surgery
Secondary	The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy	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).	30 days post-RC surgery
Secondary	The Number of Hypogonadism in Participants Based on Serum Testosterone Immediately Post Surgery Days Post Radical Cystectomy	The count of participants with hypogonadism immediately post radical cystectomy based on levels of testosterone (the level of serum testosterone used as a threshold).	Immediately post-operatively RC surgery
Secondary	The Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy	The count of participants with hypogonadism at baseline days post radical cystectomy (the level of serum testosterone used as a threshold).	Baseline, prior to RC surgery