Decision Tool for Organ-Sparing Surgery in Bladder Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Live virus vaccines

Disqualifiers: Metastatic disease, Non-urothelial cancer, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

147 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist women with bladder cancer by testing a new decision tool for surgery. Currently, the standard surgery, radical cystectomy, involves removing the bladder and several reproductive organs, which can lead to decreased sexual health and an increased risk of heart disease. The trial will compare two surgeries: one that removes all these organs and another, called reproductive organ sparing radical cystectomy, that aims to preserve the reproductive organs when safe. Women with bladder cancer who plan to have their bladder removed and meet specific medical imaging requirements might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in surgical options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot have received a live virus vaccine within 30 days before the study intervention.

What prior data suggests that this decision tool is safe for organ-sparing surgery in bladder cancer?

Research has shown that reproductive organ-sparing radical cystectomy (ROS) is safe for women with advanced bladder cancer. Studies indicate that ROS does not increase cancer recurrence or lower survival rates compared to traditional surgery, which removes more tissue. Additionally, ROS improves sexual health and overall quality of life.

One study found that surgeries preserving pelvic organs resulted in better function and quality of life for certain women. This suggests that maintaining reproductive organs when possible can offer significant benefits without compromising safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the reproductive organ sparing radical cystectomy because it offers a less invasive alternative for bladder cancer surgery. Unlike the traditional radical cystectomy, which removes the bladder and surrounding reproductive organs, this approach aims to preserve reproductive organs, potentially maintaining sexual and hormonal functions. This organ-sparing technique could significantly improve quality of life for patients by reducing the long-term side effects associated with more extensive surgeries.

What evidence suggests that this trial's treatments could be effective for bladder cancer?

This trial will compare two surgical approaches for bladder cancer: radical cystectomy and reproductive organ-sparing radical cystectomy. Research has shown that reproductive organ-sparing radical cystectomy can be effective for women with bladder cancer. Studies have found no major differences in survival rates or cancer recurrence between women who underwent this surgery and those who had their reproductive organs removed. This indicates that cancer outcomes are similar regardless of whether the reproductive organs are preserved. Additionally, preserving these organs may improve quality of life and help avoid side effects like sexual health issues and a higher risk of bone fractures. Overall, this approach could provide a balance between effective cancer treatment and a better quality of life. ^{1 3 4 6 7}

Who Is on the Research Team?

Tarik Benidir, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older with urothelial carcinoma of the bladder who are candidates for radical cystectomy. They must have at least one reproductive organ, be physically able to undergo surgery and an MRI, and not have received certain treatments recently.

Inclusion Criteria

I am eligible for major bladder surgery.

I am a woman aged 18 or older.

You are able to have a pelvic MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either radical cystectomy or reproductive organ sparing radical cystectomy based on the decision tool classification

4-6 weeks

Follow-up

Participants are monitored for safety, effectiveness, and recurrence rates after treatment

15 months

Quality of Life Assessment

Evaluate quality of life using the FACT-G questionnaire and sexual function using the FSFI

15 months

What Are the Treatments Tested in This Trial?

Interventions

• Radical cystectomy
• Reproductive organ sparing radical cystectomy

Trial Overview The study compares traditional radical cystectomy (removal of bladder and reproductive organs) with a sparing approach that preserves reproductive organs when possible. A decision tool will help determine which procedure each participant should receive.

How Is the Trial Designed?

Group I: Reproductive organ sparing radical cystectomy Experimental Treatment 1 Intervention

Group II: Radical cystectomy Active Control 1 Intervention

Radical cystectomy is already approved in United States, European Union for the following indications:

Approved in United States as OPDIVO for:

• Metastatic non-small cell lung cancer (NSCLC)
• Unresectable malignant pleural mesothelioma (MPM)
• Intermediate or poor risk advanced renal cell carcinoma (RCC)
• Advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy
• Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC)
• Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
• Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
• Adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease
• Advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
• Urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection

Approved in European Union as OPDIVO for:

• Advanced (unresectable or metastatic) melanoma
• Adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
• Metastatic NSCLC in adults whose tumours have no sensitising EGFR mutation or ALK translocation
• Locally advanced or metastatic NSCLC after prior chemotherapy in adults
• Neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%
• Unresectable malignant pleural mesothelioma
• Intermediate/poor-risk advanced RCC
• Advanced RCC after prior therapy in adults
• First-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%
• Urothelial carcinoma

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

In a study of 180 women with bladder cancer who underwent orthotopic neobladder reconstruction, the rate of urethral recurrence and overall oncological failure was found to be low, supporting the continued use of this surgical approach.

The research indicated that if preoperative imaging shows no malignancy in the internal genitalia, the risk of secondary cancer in these organs after cystectomy is very low, justifying the preservation of healthy gynecological organs during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncological outcome after radical cystectomy and orthotopic bladder substitution in women. Ali-El-Dein, B.[2022]

In a study of 273 female bladder cancer patients, those who underwent pelvic organ preserving-radical cystectomy (POPRC) showed no significant difference in overall survival compared to those who had standard radical cystectomy (SRC) after a median follow-up of 38.6 months.

Both surgical methods resulted in similar cancer-specific survival and recurrence-free survival rates, indicating that POPRC is a viable alternative to SRC without compromising long-term oncological outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival after female pelvic organ-sparing radical cystectomy versus standard radical cystectomy: a multi-institutional propensity score-matched analysis. Zhong, W., Xia, K., Liu, L., et al.[2023]

Pelvic organ-preserving radical cystectomy (POPRC) may improve sexual and urinary function outcomes compared to standard radical cystectomy (RC), with 86% of patients resuming sexual activity within 6 months and high satisfaction scores.

Oncological outcomes for POPRC appear comparable to standard RC, with cancer-specific survival rates ranging from 70-100% at 3 and 5 years, but further research is needed due to high risk of bias and variability in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the oncological and functional outcomes of pelvic organ-preserving radical cystectomy (RC) compared with standard RC in women who undergo curative surgery and orthotopic neobladder substitution for bladder cancer. Veskimäe, E., Neuzillet, Y., Rouanne, M., et al.[2018]

Radical cystectomy combined with neoadjuvant chemotherapy is the standard treatment for muscle-invasive bladder cancer, particularly in postmenopausal women, with a median diagnosis age of 73 in Sweden.

The traditional practice of performing oophorectomy alongside radical cystectomy may not be justified, as recent literature suggests that preserving the ovaries could reduce postoperative functional impairment without increasing cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should we Refrain from Performing Oophorectomy in Conjunction with Radical Cystectomy for Bladder Cancer? Liedberg, F., Jancke, G., Sörenby, A., et al.[2018]

A survey of 101 urologists revealed that while many routinely perform radical cystectomy (RC) with organ-sparing techniques in premenopausal patients, there is a significant decrease in the use of these techniques for postmenopausal patients, despite their oncological safety and potential to improve sexual function outcomes.

The study highlights a gap in the adoption of female reproductive organ-sparing and nerve-sparing techniques, suggesting a need for enhanced training and education among urologists to optimize postoperative outcomes for female patients with organ-confined bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice Patterns Regarding Female Reproductive Organ-Sparing and Nerve-Sparing Radical Cystectomy Among Urologic Oncologists in the United States. Gupta, N., Kucirka, L., Semerjian, A., et al.[2023]

Women who underwent reproductive organ-sparing cystectomy (ROSC) with orthotopic bladder substitution (OBS) experienced significantly higher daytime and nighttime urinary continence rates compared to those who had standard cystectomy (SC), with rates of 87.5% versus 63.5% and 87.5% versus 57.7%, respectively.

Despite the improved continence rates, there were no significant differences in oncological outcomes, such as local recurrence rates and overall survival rates, between the ROSC and SC groups, indicating that ROSC can be a safe and effective option for women undergoing OBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproductive organ-sparing cystectomy significantly improves continence in women after orthotopic bladder substitution without affecting oncological outcome. Gross, T., Furrer, M., Schorno, P., et al.[2019]

In a study of 123 women undergoing radical cystectomy for bladder cancer, 15% had reproductive organ involvement, with 4% specifically showing ovarian involvement, indicating a significant risk associated with advanced disease stages.

The study suggests that women with organ-confined bladder cancer (≤T2) may safely undergo ovary-sparing radical cystectomy without compromising oncologic safety, as the risk of incomplete resection of malignancy is low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gynecologic Organ Involvement During Radical Cystectomy for Bladder Cancer: Is It Time to Routinely Spare the Ovaries? Taylor, BL., Matrai, CE., Smith, AL., et al.[2019]

Reproductive organ-sparing radical cystectomy (ROSRC) may improve sexual and urinary function for patients, but careful patient selection is crucial to avoid oncologic risks, as current evidence is based on small cohorts with only intermediate-term follow-up.

While ROSRC shows promising functional benefits, the extent of these advantages is uncertain, and further long-term studies are needed to ensure oncologic safety and effective candidate selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Female reproductive organ-sparing radical cystectomy: contemporary indications, techniques and outcomes. Niver, BE., Daneshmand, S., Satkunasivam, R.[2015]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34896022/

Safety and Efficacy of Reproductive Organ-Sparing Radical ... In this analysis, ROS in women with advanced disease did not increase positive margin rates or decrease RFS, CSS, or OS compared to non-ROS.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143924006628

Oncologic outcomes of pelvic organ-preserving radical ... The comparison showed no significant differences in overall survival, cancer-specific survival, or recurrence-free survival rates.

3. wjso.biomedcentral.com wjso.biomedcentral.com/articles/10.1186/s12957-024-03502-6

Pelvic organ-preserving radical cystectomy versus standard ... Pelvic organ-preserving radical cystectomy (POPRC) has been reported to result in a better postoperative quality of life in female with bladder cancer.

4. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/full/10.1111/bju.16691

Pelvic organ‐sparing robot‐assisted radical cystectomy in ... Pelvic organ-sparing RARC could be considered in well selected women with bladder cancer, resulting in improved quality of life and functional outcomes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12410766/

Safety and Efficacy of Reproductive organ-sparing radical ... From 2000 to 2020, 289 women were identified, 188 underwent reproductive organ-sparing cystectomy. No statistical differences were noted for ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1558767321002172

Safety and Efficacy of Reproductive Organ-Sparing Radical ... Female reproductive organ-sparing (ROS) and nerve-sparing radical cystectomy (RC) techniques have been shown to be oncologically safe and to improve sexual ...

7. clinicalkey.com clinicalkey.com/#!/content/journal/1-s2.0-S1558767321002172

Safety and Efficacy of Reproductive Organ-Sparing Radical ... Safety and Efficacy of Reproductive Organ-Sparing Radical Cystectomy in Women With Variant Histology and Advanced Stage · Sunil H. Patel ·, Shirley Wang ·, ...