Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer

NCT03063125 | Completed Results

• 1 other identifier: STUDY00140348
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bladder Cancer; Low Testosterone Levels

Keywords

radical cystectomy; hypogonadism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy

  30 days post-RC surgery

• The Number of Hypogonadism in Participants Based on Serum Testosterone Immediately Post Surgery Days Post Radical Cystectomy

  Immediately post-operatively RC surgery

• The Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy

  Baseline, prior to RC surgery

Study Arms (1)

Bladder Cancer Patients

Patients with bladder cancer scheduled to undergo radical cystectomy (RC).

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligible participants are adult men undergoing RC for primary bladder cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis of bladder cancer
• Scheduled to undergo radical cystectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Hypogonadism

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Katie Glavin
• Organization: University of Kansas Medical Center

kglavin@kumc.edu

913-588-8721

Study Officials

• Jeffrey Holzbeierlein, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: March 31, 2017
• Primary Completion: April 20, 2018
• Study Completion: April 20, 2018
• Last Updated: August 3, 2021
• Results First Posted: May 10, 2021

Record last verified: 2021-07

Locations

US (1)