Bladder CancerNCT03063125
Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer
An observational study of Bladder Cancer and Low Testosterone Levels, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bladder Cancer, Low Testosterone Levels
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 20 Apr 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of bladder cancer
- Scheduled to undergo radical cystectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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
- Medical subject headings
- Urinary Bladder Neoplasms, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Cancer Patients | Patients with bladder cancer scheduled to undergo radical cystectomy (RC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90 days post-RC surgery
Secondary outcomes (3)
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).
Measured: 30 days post-RC surgery
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).
Measured: Immediately post-operatively RC surgery
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).
Measured: Baseline, prior to RC surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start31 Mar 2017
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Holzbeierlein, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063125
- Sponsor's protocol ID
- STUDY00140348
- Status last verified
- Jul 2021
- First submitted
- 21 Feb 2017
- Last updated
- 3 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer
- ClinicalTrials.gov ID
- NCT03063125
- Acronym / sponsor ID
- STUDY00140348
- Conditions
- Bladder Cancer, Low Testosterone Levels
- Keywords
- radical cystectomy, hypogonadism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Posted 10 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder Cancer Patients | – | –Patients with bladder cancer scheduled to undergo radical cystectomy (RC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of bladder cancer
- Scheduled to undergo radical cystectomy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
3 secondary outcomes
The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy
Time frame: 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 Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy
Time frame: Baseline, prior to RC surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Holzbeierlein, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Low Testosterone Levels, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Hypogonadism in Participants Based on Serum Testosterone 90 Days Post Radical (time frame: 90 days post-RC surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.