Guidance of Adjuvant Instillation in Intermediate Risk Non-muscle Invasive Bladder Cancer by Drug Screens in Patient Derived Organoids. A Single Center, Open-label, Phase II Trial With a Feasibility Endpoint. (GAIN-INST-TRIAL)
Who is this study for? Patients with intermediate risk non-muscle invasive bladder cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Switzerland
Spitalzentrum Biel/Bienne
RECRUITING
Biel
Contact Information
Primary
Roland Seiler-Blarer, MD
urologie@szb-chb.ch
+41 32 324 32 06
Backup
Martina Schneider, PhD
Martina.Schneider@szb-chb.ch
+4132 324 32 17
Time Frame
Start Date:2023-02-21
Estimated Completion Date:2027-10-31
Participants
Target number of participants:34
Treatments
Experimental: Epirubicin
Patients in that PDOs show highest response to this drug in-vitro will be treated with Epirubicin.~If no significant drug selection can be performed in-vitro, Epirubicin will be the default for instillation.
Experimental: Mitomycin
Patients in that PDOs show highest response to this drug in-vitro will be treated with Mitomycin.
Experimental: Gemcitabine
Patients in that PDOs show highest response to this drug in-vitro will be treated with Gemcitabine.
Experimental: Docetaxel
Patients in that PDOs show highest response to this drug in-vitro will be treated with Docetaxel.