Mitomycin for Recurrent non-muscle invasive bladder cancer

Inclusion criteria

• {"criterion_text":"-•\tTumour recurrence after previous urothelial tumour of Ta low-grade (previous Ta high-grade is allowed, but latest histology must be Ta low-grade)"}
• {"criterion_text":"-•\tLargest tumour smaller than 2 cm in diameter"}
• {"criterion_text":"-•\tNegative urine cytology (optional)"}
• {"criterion_text":"-•\t≥18 years of age"}
• {"criterion_text":"-•\tAbility to understand and comprehend the provided written and oral information"}
• {"criterion_text":"-•\tThe patient's mental well-being is assured"}

Exclusion criteria

• {"criterion_text":"-•\tKnown history of invasive tumour of the bladder (T1+)"}
• {"criterion_text":"-•\tSuspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious flat lesions seen at cystoscopy)"}
• {"criterion_text":"-•\tSmall bladder volume (less than 100 ml) or profuse incontinence >50 grams a day"}
• {"criterion_text":"-•\tPrior radiation therapy to the pelvic area"}
• {"criterion_text":"-•\tTumour in the bladder neck if it is visually evaluated as placed in an area being non-exposed to MMC during chemoablation"}
• {"criterion_text":"-•\tUrothelial carcinoma outside of the urinary bladder or a histological variant of urothelial carcinoma. Ta/any T1 or CIS of the upper urinary tract is allowed if treated with complete nephroureterectomy more than 24 months prior to enrolment and without any evidence of recurrence"}
• {"criterion_text":"-•\tPermanent indwelling catheter if not using a valve"}
• {"criterion_text":"-•\tKnown immunosupressed or known autoimmune disease"}
• {"criterion_text":"-•\tNon-treated Aacute cystitis at enrolment"}
• {"criterion_text":"-•\tPregnancy or breast-feeding"}
• {"criterion_text":"-•\tAverse to using secure contraception with regard to men with partners and premenopausal women"}
• {"criterion_text":"-•\tKnown history of CIS of the bladder"}
• {"criterion_text":"-•\tPrevious MMC or BCG-treatment within the last 3 years except for single instillations following previous TURBT or nephoureterectomy"}
• {"criterion_text":"-•\tKnown allergy or intolerance to MMC or BCG"}
• {"criterion_text":"-•\tSolid tumour with suspicions of invasion"}
• {"criterion_text":"-•\tTumour in the urethra"}

Primary endpoints

• {"endpoint_text":"-•\tTwo-year RFS. This is defined as event of first recurrence following treatment but not including the recurrence diagnosed at the time of inclusion or persisting tumour following chemoablation.","definition_or_measurement_approach":"This is defined as event of first recurrence following treatment but not including the recurrence diagnosed at the time of inclusion or persisting tumour following chemoablation."}

Secondary endpoints

• {"endpoint_text":"-•\tFive-year RFS","definition_or_measurement_approach":""}
• {"endpoint_text":"-•\tNumber of patients in need of a TURBT or tumour fulguration in the outpatient clinic in the first two years following randomisation","definition_or_measurement_approach":"Count of patients requiring TURBT or tumour fulguration in outpatient clinic within first two years after randomisation."}
• {"endpoint_text":"-•\tNumber of tumours at first recurrence based on the following intervals: 1, 2-7, > 8","definition_or_measurement_approach":"Number of tumours at first recurrence categorized into intervals 1, 2-7, >8."}
• {"endpoint_text":"-•\tNumber of TURBTs per patient in the first two and five years of follow-up based on the following intervals: 1, 2-5, 5-10 and multiple","definition_or_measurement_approach":"Number of TURBT procedures per patient over first two and five years, categorized into intervals 1, 2-5, 5-10 and multiple."}
• {"endpoint_text":"-•\tFive-year progression free survival (progression defined as progression to T1-tumour, T2+-tumour, or cystectomy irrespectively of indication)","definition_or_measurement_approach":"Progression-free survival defined as time to progression to T1 tumour, T2+ tumour, or cystectomy irrespective of indication, assessed up to five years."}
• {"endpoint_text":"-•\tFive-year overall survival","definition_or_measurement_approach":"Overall survival assessed up to five years."}
• {"endpoint_text":"-•\tNumber of patients completing assigned intervention","definition_or_measurement_approach":"Count of patients who complete the assigned intervention."}
• {"endpoint_text":"-•\tSerious adverse events related to MMC treatment during neoadjuvant or adjuvant therapy","definition_or_measurement_approach":"Number and description of serious adverse events assessed as related to MMC during neoadjuvant or adjuvant therapy."}

Denmark

Latest Decision Or Authorization Date

19-03-2026

Number Of Sites

5

Number Of Participants

145

Iceland

Latest Decision Or Authorization Date

17-03-2026

Number Of Sites

1

Number Of Participants

25

Norway

Latest Decision Or Authorization Date

13-04-2026

Number Of Sites

2

Number Of Participants

45

Sweden

Latest Decision Or Authorization Date

13-04-2026

Number Of Sites

1

Number Of Participants

25

Primary sponsor

Full Name

Aarhus University

Organisation Type

Educational Institution

Country Of Registered Address

Denmark

Third parties

• {"country":"","full_name":"medac GmbH","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"codes: 1,8,9","organisation_type":"Educational Institution"}