Personalized treatment for non-muscle invasive bladder cancer using patient-derived organoids
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)
PHASE2 · Hospital Centre Biel/Bienne · NCT05024734
This study is testing if personalized lab-grown versions of patients' tumors can help find the best chemotherapy treatment for people with intermediate risk non-muscle invasive bladder cancer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Centre Biel/Bienne (other) |
| Locations | 1 site (Biel) |
| Trial ID | NCT05024734 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients with intermediate risk non-muscle invasive bladder cancer. Tumor specimens will be collected during surgery and cultured into patient-derived organoids (PDO). These organoids will be tested against various intravesical chemotherapy agents to determine which drug has the highest anti-tumor effect. The most effective drug will then be administered to patients through weekly intravesical instillations for six weeks, followed by standard care monitoring.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed intermediate risk non-muscle invasive urothelial carcinoma of the bladder.
Not a fit: Patients with a history of high-grade or high-risk non-muscle invasive bladder cancer or those who have received prior intravesical therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with non-muscle invasive bladder cancer.
How similar studies have performed: While this approach is innovative, similar studies using patient-derived organoids for drug screening have shown promise in other cancer types, indicating potential for success in this context.
Eligibility criteria
Show full 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.
Where this trial is running
Biel
- Spitalzentrum Biel/Bienne — Biel, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Roland Seiler-Blarer, MD
- Email: urologie@szb-chb.ch
- Phone: +41 32 324 32 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bladder Cancer, Non-muscle Invasive