drugset / Trial / NCT05024734

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

NCT05024734

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-02-21
Primary completion
2026-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 37.5 mg Intrathecal
Subject Epirubicin Small molecule 50 mg Intrathecal
Subject Gemcitabine Small molecule 1000 mg Intrathecal
Subject Mitomycin C Other / unclassified 20 mg Intrathecal