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