Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids

• Status: Not yet recruiting
• Trial end date: 2026-05-30
• Target enrollment: 0
• Participant gender: All

Summary

From patients with intermediate risk non-muscle invasive bladder cancer tumor (NMIBC) specimens will be harvested during transurethral resection. Fresh specimens will be cultured as patient derived organoids (PDO). After approx. 10 days, PDO are exposed to different drugs that are used as intravesical instillation agents in these patients (epirubicin, mitomycin, gemcitabine, docetaxel). After 2 days of exposure, PDO viability will be measured. The drug with the highest antitumor effect on PDO will be applied as weekly intravesical instillations 6 times. Thereafter, patients are followed according to the standard of care.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: Hospital Centre Biel/Bienne; University of Bern
• Treatments: Docetaxel; Epirubicin; Gemcitabine; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Signed Informed Consent Form

• ECOG performance status of 0 or 1

• Histologically confirmed intermediate risk non muscle-invasive urothelial carcinoma of the bladder (pTa low grade) Patients

• Representative fresh tumor specimen for PDO generation and drug screen

Exclusion Criteria:

• Known previous high grade and/or high risk non muscle-invasive bladder cancer

• Previous Intravesical biological/immuno (BCG) therapy

• Pregnancy or nursing

• Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol

• Severe infection within 4 weeks prior to cycle 1, day 1

• Contraindication for frequent catheterization

• Voiding dysfunction