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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

Qualifiers

Female ≥ eighteen years of age

Histologically proven diagnosis of urothelial carcinoma of the bladder, including variant histology

Surgical candidate for radical cystectomy

MRI of the pelvis on 1.5T or higher strength magnet.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Reproductive organ sparing radical cystectomy
  • Radical cystectomy

Treatment groups

127 Participants
are divided into 2 treatment groups

Sponsors and collaborators