Urothelial Carcinoma BladderPhase 2NCT06184516
Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy
A Phase 2 study testing Reproductive organ sparing radical cystectomy and Radical cystectomy in people with Urothelial Carcinoma Bladder, run by University of Florida at 1 site in United States.
Trial summary
Currently, the standard of care for female patients undergoing radical cystectomy includes the removal of the bladder, pelvic lymph nodes, anterior vagina, uterus, fallopian tubes and ovaries. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Urothelial Carcinoma Bladder
- What is being tested?
- Reproductive organ sparing radical cystectomy and Radical cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2024to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ≥ eighteen years of age
- Histologically proven diagnosis of urothelial carcinoma of the bladder, including variant histology
- Surgical candidate for radical cystectomy
- Be able to undergo pelvic MRI. Minimum standards for MRI imaging will include the following:
- MRI of the pelvis on 1.5T or higher strength magnet.
- T2 weighted imaging in multiple planes.
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- T1 weighted imaging pre and post contrast administration (unless contrast is contraindicated by allergy or renal insufficiency)
- Cystoscopic evaluation completed by urologist within 120 days prior to surgery (ROS-RC or RC)
- Staging imaging within 90 days prior to surgery (ROS-RC or RC). If receiving neoadjuvant therapy prior to surgery (ROS-RC or RC), repeat staging imaging must be completed after the neoadjuvant therapy is completed, or no longer tolerated by the patient.
- Staging imaging must include MRI of the pelvis within 90 days of surgery (ROS-RC or RC)
- Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.
- Presence of at least one or more ancillary organs. Ancillary organs defined as anterior vagina, uterus, fallopian tubes (only 1 tube present will be considered at physician discretion), and ovaries.
- ECOG Performance Status of 0-2
Who cannot join
- Patients with regional or distant metastatic disease
- Non-urothelial bladder cancer.
- Not a surgical candidate for radical cystectomy
- Unable to have MRI of pelvis that meets the minimum standards in the inclusion criteria above.
- Subjects of childbearing potential (SOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during study intervention and for at least 12 weeks after the study intervention.
- Patients with other known active malignancies which may confound the recurrence rates
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- Patients with known germline mutations in DNA damage repair genes (BRCA1/BRCA 2)
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
- Subjects who are confirmed to be pregnant or breastfeeding.
- History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for complications, in the opinion of the treating physician.
- Administration of a vaccine containing live virus within 30 days prior to the study intervention. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID vaccine are allowed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
Nicole Davila Torres, 352-273-6913, ndavilatorres@ufl.edu
Brittany S Lansford, (352) 273-5045, bpolo6962@ufl.edu
About this study
Currently, the standard of care for female patients undergoing radical cystectomy includes the removal of the bladder, pelvic lymph nodes, anterior vagina, uterus, fallopian tubes and ovaries. Removal of female ancillary organs, both in pre and post-menopausal stages is associated with reduction in various quality of life metrics, including sexual health, cognitive decline and depression. Furthermore, removal of ovaries has been associated with increased cardiovascular events, metabolic acidosis, osteoporosis and bone fractures. In premenopausal women, the removal of the ovaries is associated with increased all-cause mortality. From an oncologic standpoint, multi institutional retrospective reviews have demonstrated certain pre-operative radiographic and cystoscopic risk factors that are associated with bladder cancer involvement of female reproductive organs. The absence of these unfavorable risk factors may provide an opportunity to spare women from undergoing unnecessary reproductive organ removal during RC. In doing so, this may eliminate the associated sequelae of removing these additional organs while also providing acceptable oncologic care. The investigators thus propose a decision tool to stratify women undergoing radical cystectomy as favorable and unfavorable for reproductive organ sparing radical cystectomy. This decision tool classification will be used to decide which patients will undergo reproductive organ sparing radical cystectomy versus radical cystectomy in this study.
- Conditions
- Urothelial Carcinoma Bladder
- Being tested
- Reproductive organ sparing radical cystectomy, Radical cystectomy
- Keywords
- urothelial carcinoma, radical cystectomy, organ preservation, female
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reproductive organ sparing radical cystectomyProcedure or surgery
Participants on this arm will undergo a reproductive organ sparing radical cystectomy if they are classified as "favorable" based on the decision tool.
Radical cystectomyProcedure or surgery
Participants on this arm will undergo a radical cystectomy if they are classified as "unfavorable" based on the decision tool.
| Study group | Role | What they receive |
|---|---|---|
| Reproductive organ sparing radical cystectomy | Experimental | Not described Receives: Procedure: Reproductive organ sparing radical cystectomy |
| Radical cystectomy | Active comparator | Not described Receives: Procedure: Radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive margin rate
Determine the positive margin status rate (based on the surgical pathology report) for the favorable cohort who successfully undergo reproductive organ sparing radical cystectomy
Measured: 120 days
Secondary outcomes (7)
Sexual function
Evaluate sexual function as measured by the Female Sexual Function Index (FSFI). The FSFI consists of 19 questions measuring female sexual function across six domains, including desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items), and pain (3 items). Each response is assigned a score of either 0 to 5 or 1 to 5, with a higher score meaning a greater level of sexual functioning. The scores are summed to produce a composite score ranging from 4 to 36, with a higher score meaning better sexual functioning.
Measured: 15 months
Quality of life
Evaluate quality of life as measured by the FACT-G questionnaire. The FACT-G measures various aspects of physical, social, emotional, and functional well-being over the past 7 days on a scale of 0-4 (with 0 meaning "Not at all" and 4 meaning "Very much").
Measured: 15 months
Local recurrence
Determine the local recurrence rate.
Measured: 12 months
Distant recurrence
Determine the distant recurrence rate.
Measured: 12 months
Incidence rate of adjacent pelvic organ involvement
Determine the incidence of adjacent pelvic organ involvement in women undergoing radical cystectomy deemed "unfavorable" based on the decision tool.
Measured: 12 months
Prediction of extravesicular disease
Evaluate the ability of staging MRI of the pelvis to predict extravesicular disease.
Measured: 15 months
Prediction of adjacent pelvic organ involvement
Evaluate the ability of staging MRI of the pelvis to predict adjacent pelvic organ involvement
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start30 Aug 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma BladderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarik Benidir, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184516
- Sponsor's protocol ID
- UF-GU-008
- Other IDs
- OCR44653, IRB202400006
- Status last verified
- Jun 2026
- First submitted
- 14 Dec 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy
- ClinicalTrials.gov ID
- NCT06184516
- Acronym / sponsor ID
- UF-GU-008
- Conditions
- Urothelial Carcinoma Bladder
- Keywords
- urothelial carcinoma, radical cystectomy, organ preservation, female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, the standard of care for female patients undergoing radical cystectomy includes the removal of the bladder, pelvic lymph nodes, anterior vagina, uterus, fallopian tubes and ovaries. Removal of female ancillary organs, both in pre and post-menopausal stages is associated with reduction in various quality of life metrics, including sexual health, cognitive decline and depression. Furthermore, removal of ovaries has been associated with increased cardiovascular events, metabolic acidosis, osteoporosis and bone fractures. In premenopausal women, the removal of the ovaries is associated with increased all-cause mortality. From an oncologic standpoint, multi institutional retrospective reviews have demonstrated certain pre-operative radiographic and cystoscopic risk factors that are associated with bladder cancer involvement of female reproductive organs. The absence of these unfavorable risk factors may provide an opportunity to spare women from undergoing unnecessary reproductive organ removal during RC. In doing so, this may eliminate the associated sequelae of removing these additional organs while also providing acceptable oncologic care. The investigators thus propose a decision tool to stratify women undergoing radical cystectomy as favorable and unfavorable for reproductive organ sparing radical cystectomy. This decision tool classification will be used to decide which patients will undergo reproductive organ sparing radical cystectomy versus radical cystectomy in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reproductive organ sparing radical cystectomy | Experimental | Procedure: Reproductive organ sparing radical cystectomy |
| Radical cystectomy | Active comparator | Procedure: Radical cystectomy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female ≥ eighteen years of age
- Histologically proven diagnosis of urothelial carcinoma of the bladder, including variant histology
- Surgical candidate for radical cystectomy
- Be able to undergo pelvic MRI. Minimum standards for MRI imaging will include the following:
- Cystoscopic evaluation completed by urologist within 120 days prior to surgery (ROS-RC or RC)
Key exclusion criteria (13 listed)
- Patients with regional or distant metastatic disease
- Non-urothelial bladder cancer.
- Not a surgical candidate for radical cystectomy
- Unable to have MRI of pelvis that meets the minimum standards in the inclusion criteria above.
- Subjects of childbearing potential (SOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during study intervention and for at least 12 weeks after the study intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reproductive organ sparing radical cystectomyParticipants on this arm will undergo a reproductive organ sparing radical cystectomy if they are classified as "favorable" based on the decision tool. | Procedure or surgery | Reproductive organ sparing radical cystectomy |
| Radical cystectomyParticipants on this arm will undergo a radical cystectomy if they are classified as "unfavorable" based on the decision tool. | Procedure or surgery | Radical cystectomy |
Primary outcome
Positive margin rate
Time frame: 120 days
Determine the positive margin status rate (based on the surgical pathology report) for the favorable cohort who successfully undergo reproductive organ sparing radical cystectomy
7 secondary outcomes
Sexual function
Time frame: 15 months
Quality of life
Time frame: 15 months
Local recurrence
Time frame: 12 months
Distant recurrence
Time frame: 12 months
Incidence rate of adjacent pelvic organ involvement
Time frame: 12 months
Prediction of extravesicular disease
Time frame: 15 months
Prediction of adjacent pelvic organ involvement
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
Tarik Benidir, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reproductive organ sparing radical cystectomy and Radical cystectomy in people with Urothelial Carcinoma Bladder, run by University of Florida 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 13 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Davila Torres (352-273-6913, ndavilatorres@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive margin rate (time frame: 120 days). 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 9 Sep 2026.