Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05979909

Enrollment

Registered

2023-08-07

Start date

2023-09-30

Completion date

2027-09-30

Last updated

2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma Ureter

Brief 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.

Interventions

DRUGMitomycin C

Mitomycin (40 mg in 40 mL of sterile water) will be administered through a Foley catheter, which will be clamped for two hours.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Suspected upper tract urothelial carcinoma (UTUC) * Diagnostic ureteroscopy required * Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy

Exclusion criteria

* Prior or concomitant urothelial carcinoma of the bladder * History of UTUC * Ureteroscopy within the preceding six months * Untreated urinary tract infection * Suspected or confirmed perforation of the upper or lower urinary tract * Lower urinary tract fistula * Leukopenia or thrombocytopenia * ECOG performance status 2 or greater * Known hypersensitivity to mitomycin C * Pregnancy or breastfeeding * Lack of capacity to consent

Design outcomes

Primary

Measure	Time frame	Description
Recruitment rate	30 days	Proportion of patients who consent to participate in the study after being invited to do so
Randomization rate	30 days	Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms
Retention rate	2 years	Proportion of randomized patients who complete follow-up

Secondary

Measure	Time frame	Description
Adverse events (any)	30 days	Cumulative incidence of adverse events
Adverse events (severe)	30 days	Cumulative incidence of grade 3-5 adverse events
Intravesical recurrence	2 years	Cumulative incidence of urothelial carcinoma of the bladder

Contacts

Primary ContactPiotr Zareba, MD MPH

zareba@hhsc.ca(905) 521-2100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026