A Decision Tool for the Selection of Women with Localized Urothelial Bladder Cancer for Reproductive Organ Sparing Radical Cystectomy

Inclusion Criteria

• Female ≥ eighteen years of age
• Histologically proven diagnosis of urothelial carcinoma of the bladder, including variant histology
• Surgical candidate for RC
• Be able to undergo pelvic MRI. Minimum standards for MRI imaging will include the following: * MRI of the pelvis on 1.5 tesla (T) 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
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria

• Patients with regional or distant metastatic disease
• Non-urothelial bladder cancer
• Not a surgical candidate for RC
• Unable to have MRI of pelvis that meets the minimum standards in 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 (RC) * SOCBP includes any subject who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal litigation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopausal is defined as: ** Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or ** For subjects with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL
• Patients with other known active malignancies which may confound the recurrence rates
• Patients with known germline mutations in deoxyribonucleic acid (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 (RC). 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 coronavirus disease (COVID) vaccine are allowed