Chemoablation versus bladder resection with adjuvant chemotherapy for recurrent Ta low-grade bladder tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, multicenter trial comparing dose-dense intravesical Mitomycin C chemoablation (with adjuvant BCG for those who do not respond) against standard transurethral resection of bladder tumors (TURBT) followed by adjuvant intravesical therapy in patients with recurrent Ta low-grade bladder cancer. The trial builds on the pivotal NICSA results and uses a patient-tailored approach to improve long-term outcomes and confirm prior findings. Eligible patients have small (<2 cm) recurrent Ta low-grade tumors and will be randomized to one of the two treatment pathways, with standardized follow-up to measure recurrence rates over time. The primary focus is on durable recurrence reduction while capturing safety and functional bladder outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Tumour recurrence after previous urothelial tumour of Ta low-grade
* Tumours smaller than 2 cm in diameter
* Negative urine cytology (optional)
* ≥18 years of age
* Ability to understand and comprehend the provided written and oral information
* Has provided written consent

Exclusion Criteria:

* Known history of invasive tumour of the bladder (T1+)
* Known history of CIS of the bladder
* Previous MMC or BCG-treatment except for single instillations following previous TURBTs
* Known allergy or intolerance to MMC
* Solid tumour with suspicions of invasion
* Tumour in the bladder neck or urethra
* Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious flat lesions seen at cystoscopy)
* Small bladder volume (less than 100 ml) or incontinence
* Prior radiation therapy to the pelvic area, as radiation affects the bladder function and instillation therapy is a suboptimal treatment for this patient group
* Acute cystitis
* Pregnancy or breast-feeding
* Averse to using secure contraception with regard to men with partners and premenopausal women

Where it's running

• Aarhus University Hospital
  Aarhus N, Denmark Recruiting
• Herlev and Gentofte Hospital
  Herlev, Denmark Recruiting
• Zealand University Hospital, Roskilde
  Roskilde, Denmark Recruiting
• Aalborg University Hospital
  Aalborg, Denmark Not yet recruiting
• Landspítali University Hospital
  Reykjavik, Iceland Not yet recruiting
• Haukeland University Hospital
  Bergen, Norway Not yet recruiting

Study contacts

• Study coordinator: Pernille Kingo, PhD, Dr
• Email: pernking@rm.dk
• Phone: 0045 78 45 00 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.