Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer

July 30, 2021 updated by: University of Kansas Medical Center
The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from patients being treated at the University of Kansas Health System.Potiential patients will be recruited from the urology clinic, University of Kansas Cancer Center or during inpatient hospitalization.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Bladder Cancer Patients
Patients with bladder cancer scheduled to undergo radical cystectomy (RC).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy
Time Frame: 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).
30 days post-RC surgery
The Number of Hypogonadism in Participants Based on Serum Testosterone Immediately Post Surgery Days Post Radical Cystectomy
Time Frame: 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).
Immediately post-operatively RC surgery
The Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy
Time Frame: 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).
Baseline, prior to RC surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Jeffrey Holzbeierlein, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2017

Primary Completion (Actual)

April 20, 2018

Study Completion (Actual)

April 20, 2018

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00140348

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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