Preventing Intravesical Recurrence in Patients With Urothelial Carcinoma of the Upper Urinary Tract: a Pilot Randomized Trial of a Single Prophylactic Bladder Instillation of Mitomycin C After Diagnostic Ureteroscopy
Status: Not_yet_recruiting
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The objective of this pilot study is to determine the feasibility of conducting a phase III randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). In the current study, 40 patients will be randomized to receive MMC or no intervention and will be followed for two years to determine the incidence of adverse events and IVR.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Suspected upper tract urothelial carcinoma (UTUC)
• Diagnostic ureteroscopy required
• Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy
Contact Information
Primary
Piotr Zareba, MD MPH
zareba@hhsc.ca
(905) 521-2100
Time Frame
Start Date: 2023-09
Completion Date: 2027-09
Participants
Target number of participants: 40
Treatments
Experimental: Intravesical mitomycin C (MMC)
No_intervention: No intervention
Related Therapeutic Areas
Sponsors
Leads: McMaster University