Superficial Bladder Cancer: Selection of the Optimal Bladder Irrigation with a Chemotherapeutic Based on Personalized Primary Tumor Cultures
Summary description of the study
In patients with superficial bladder cancer, tumor samples are cultured and the efficacy of 4 different chemotherapeutics is tested on these personalized cultures. The drug that shows the highest efficacy in the tumor model is selected. The bladder is then irrigated on an outpatient basis 6 times at weekly intervals with the drug after surgery to prevent recurrence.
(BASEC)
Intervention under investigation
The four drugs are already in clinical use for this condition, they show different efficacy and are currently used according to the urologist's preference and availability in the hospital. We wanted to test whether we could use primary cultures from superficial bladder cancer to test these chemotherapeutics. The information obtained should then help in the clinic to make a personalized decision regarding the choice of the appropriate drug.
(BASEC)
Disease under investigation
Superficial bladder cancer, well-differentiated and low-aggressive
(BASEC)
Superficial bladder cancer, well-differentiated and low-aggressive > 18 years First diagnosis (BASEC)
Exclusion criteria
Previous injuries and scars of the urethra Aggressive bladder cancer Recurrent urinary tract infections Pregnancy and breastfeeding (BASEC)
Trial sites
Other
(BASEC)
Klinik für Urologie Spitalzentrum Biel
(BASEC)
Sponsor
Spitalzentrum Biel, 2501 Biel, Switzerland Represented by: Prof. Dr. med. Roland Seiler-Blarer, Chairman Department of Urology, Spitalzentrum Biel Vogelsang 84, 2501 Biel, Switzerland
(BASEC)
Contact
Contact Person Switzerland
Roland Seiler-Blarer
+41 32 324 32 06
Roland.Seiler-Blarer@clutterszb-chb.chDepartment of Urology, Spitalzentrum Biel Vogelsang 84, 2501 Biel, Switzerland
(BASEC)
General Information
Department of Urology
+41 32 324 32 06+41 32 324 32 06
urologie@szb-chb.chr_seiler@gmx.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
14.12.2022
(BASEC)
ICTRP Trial ID
NCT05024734 (ICTRP)
Official title (approved by ethics committee)
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. (BASEC)
Academic 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) (ICTRP)
Public title
Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids (ICTRP)
Disease under investigation
Bladder CancerNon-muscle Invasive (ICTRP)
Intervention under investigation
Drug: EpirubicinDrug: MitomycinDrug: GemcitabineDrug: Docetaxel (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion 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. (ICTRP)
not available
Primary and secondary end points
Proportion of patients with successful drug selection (ICTRP)
Proportion of patients for whom patient-derived organoids (PDOs) can be successfully generated (regardless of subsequent drug screen);Rate of recurrence in the study population;Recurrence free survival 24 months after TURBT;Progression free survival 24 months after TURBT;General quality of Life;Quality of Life related to the bladder cancer;Safety profile of instillations (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
University of Bern;Hospital Centre Biel/Bienne (ICTRP)
Additional contacts
Roland Seiler-Blarer, MDRoland Seiler-Blarer, MDRoland Seiler-Blarer, Prof., urologie@szb-chb.chr_seiler@gmx.ch, +41 32 324 32 06+41 32 324 32 06, Department of Urology (ICTRP)
Secondary trial IDs
SZB-URO-21-001 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05024734 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available