Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy

Launched by UNIVERSITY OF FLORIDA · Dec 14, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new decision-making tool to help doctors determine if women with bladder cancer can safely avoid the removal of their reproductive organs during surgery. Traditionally, women undergoing radical cystectomy, which involves removing the bladder due to urothelial carcinoma (a type of bladder cancer), also have their pelvic organs taken out. This can lead to various health issues, including problems with sexual health, mental health, and bone health. The goal of this study is to identify women who do not have certain risk factors for cancer spreading to these organs, so they might be able to keep them during surgery, thus improving their quality of life.

To be eligible for the trial, participants must be women aged 18 or older with a confirmed diagnosis of bladder cancer who are candidates for surgery. They should be able to undergo specific imaging tests like an MRI, and have had recent evaluations of their bladder condition. Participants will need to provide consent and can expect to be part of a study that may change how surgeries for bladder cancer are performed, potentially leading to better outcomes for women in the future. It's important to note that women who are pregnant, breastfeeding, or have certain other health issues may not be eligible to participate.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 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
• Exclusion Criteria:
• • 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
• • 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.