Chemoablation versus bladder resection with adjuvant chemotherapy for recurrent Ta low-grade bladder tumors
Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer
PHASE4 · Aarhus University Hospital · NCT06781879
This study will test whether a dose-dense Mitomycin C chemoablation approach (with adjuvant BCG for non-responders) works better than standard TURBT plus intravesical therapy for adults with small recurrent Ta low-grade bladder tumors.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 272 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 8 sites (Aalborg and 7 other locations) |
| Trial ID | NCT06781879 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with recurrent Ta low-grade bladder tumors smaller than 2 cm, able to consent, without prior invasive disease or CIS and without prior MMC/BCG exposure beyond single post‑TURBT instillations are the ideal candidates.
Not a fit: Patients with a history of invasive bladder cancer (T1+), carcinoma in situ, tumors >2 cm or suspicious for invasion, bladder neck/urethral tumors, prior pelvic radiation, active cystitis, or who are pregnant are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower long-term recurrence rates and spare some patients from repeated surgical resections.
How similar studies have performed: A prior pivotal NICSA trial supported by the Danish Cancer Society showed promising results and prompted initial changes in European guidelines, so this trial is a follow-up to confirm and extend those findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aalborg and 7 other locations
- Aalborg University Hospital — Aalborg, Denmark (NOT_YET_RECRUITING)
- Aarhus University Hospital — Aarhus N, Denmark (RECRUITING)
- Herlev and Gentofte Hospital — Herlev, Denmark (RECRUITING)
- Zealand University Hospital, Roskilde — Roskilde, Denmark (RECRUITING)
- Landspítali University Hospital — Reykjavik, Iceland (NOT_YET_RECRUITING)
- Haukeland University Hospital — Bergen, Norway (NOT_YET_RECRUITING)
- Vestfold Hospital Trust — Tønsberg, Norway (NOT_YET_RECRUITING)
- NU Hospital Group — Uddevalla, Sweden (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Pernille Kingo, PhD, Dr
- Email: pernking@rm.dk
- Phone: 0045 78 45 00 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-Muscle Invasive Bladder Cancer, Recurrence, Ta low.grade, Chemoablation