Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05024734

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Non-muscle Invasive Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Spitalzentrum Biel/Bienne

Biel, 2501, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epirubicin

Drug

In PDOs from patients that show highest response to Epirubicin, this drug will be instilled intravesically once weekly for 6 times.

Epirubicin is also the default drug, in case of failure of drug prediction in the in-vitro drug screen in PDO.

Epirubicin will be used as a concentrate for injection/instillation 2 mg/ml in total 50mg per vial. Prior to use, the concentrate for injection is diluted with 25ml of 0.9% saline solution to obtain the final Solution with 1mg/ml of Epirubicin.

Mitomycin

Drug

In PDOs from patients that show highest response to Mitomycin, this drug will be instilled intravesically once weekly for 6 times.

Mitomycin C will be used as 20mg dry powder. Prior to use, the powder will be dissolved in 50ml of 0.9% saline solution according to the manufacturer instructions

Gemcitabine

Drug

In PDOs from patients that show highest response to Gemcitabine, this drug will be instilled intravesically once weekly for 6 times.

Gemcitabine will be used as 2000 mg/50ml. For intravesical application, 1000mg of gemcitabine (corresponding to 25ml) will be diluted in 25ml 0.9% saline solution, to obtain the gemcitabine concentration of 1000mg/50ml used for instillation.

docetaxel

Drug

In PDOs from patients that show highest response to Docetaxel, this drug will be instilled intravesically once weekly for 6 times.

Docetaxel will be used as 140mg/7ml solution. For intravesical application, 48.825ml of saline will be added to 1.875ml Docetaxel solution (according 37.5mg of Docetaxel). The concentration of this solution is 0.74mg/ml by a total volume of the instillation solution of 50,7.

Primary outcomes

  1. Proportion of patients with successful drug selection

    Time frame: 24 months

    Proportion of patients for which a specific selection of chemotherapeutic agent for intravesical instillation can be determined by using drug screens in PDOs.

Secondary outcomes

  1. Proportion of patients for whom patient-derived organoids (PDOs) can be successfully generated (regardless of subsequent drug screen)

    Time frame: 24 months

    Proportion of patients for whom patient-derived organoids (PDOs) can be successfully generated (regardless of subsequent drug screen)

  2. Rate of recurrence in the study population

    Time frame: 24 months

    Rate of recurrence in the study population

  3. Recurrence free survival 24 months after TURBT

    Time frame: 24 months

    Proportion of patients that show recurrence 24 months after TURBT

  4. Progression free survival 24 months after TURBT

    Time frame: 24 months

    Proportion of patients that show progression 24 months after TURBT

  5. General quality of Life

    Time frame: 24 months

    Description of the general quality of life based on the questionnaire EORTC-QLQ-C30

  6. Quality of Life related to the bladder cancer

    Time frame: 24 months

    Description of the Quality of Life related to the bladder cancer based on the specific NMIBC24 module

  7. Safety profile of instillations

    Time frame: 24 months

    Description of the side effects related to the chemotherapeutic intravesical instillations occuring during the treatment phase.

Sponsors and collaborators

Lead sponsor

Roland Seiler-Blarer

Other

Collaborators

  • Hospital Centre Biel/Bienne
  • University of Bern

Registry information

Official study 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)

Acronym: GAIN-INST

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Aug 27, 2021
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.