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Completed

NCT Number: NCT03063125

Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer

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

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Key information

Conditions

Bladder Cancer Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gonadal Disorders Hypogonadism Low Testosterone Levels Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 24, 2017
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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