Clinical trial NCT05024734: Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Bladder Cancer
Non-muscle Invasive
Lead sponsor: Hospital Centre Biel/Bienne
Sponsor class: OTHER
Collaborators: name: University of Bern
name: Hospital Centre Biel/Bienne
First posted: 2021-08-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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
* Pregnancy or nursing
* Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 6 months after the last treatment.
* Male subject who is unwilling to use acceptable method of effective contraception during IP treatment and through 6 months after the last dose of IP.

Primary outcomes:
measure: Proportion of patients with successful drug selection
timeFrame: 24 months
Secondary outcomes:
measure: Proportion of patients for whom patient-derived organoids (PDOs) can be successfully generated (regardless of subsequent drug screen)
timeFrame: 24 months
measure: Rate of recurrence in the study population
timeFrame: 24 months
measure: Recurrence free survival 24 months after TURBT
timeFrame: 24 months
measure: Progression free survival 24 months after TURBT
timeFrame: 24 months
measure: General quality of Life
timeFrame: 24 months
measure: Quality of Life related to the bladder cancer
timeFrame: 24 months
measure: Safety profile of instillations
timeFrame: 24 months
Other outcomes:
Locations:
city: Biel
country: Switzerland
facility: Spitalzentrum Biel/Bienne
Study officials:
affiliation: Department of Urology
name: Roland Seiler-Blarer, MD
role: STUDY_CHAIR
References: