Actively Recruiting
Chemoablation for Low-Grade Bladder Cancer
Led by Ekaterina Laukhtina · Updated on 2025-06-13
47
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.
CONDITIONS
Official Title
Chemoablation for Low-Grade Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Histologically confirmed diagnosis of recurrent or primary Ta low-grade bladder cancer within 8 weeks before screening
- Largest tumor diameter of 15 mm or less on cystoscopy
- Five or fewer bladder lesions
- Cystoscopy with bladder diagram, including tumor number, site, size, and appearance, with photo documentation
- Recurrence limited to Ta low-grade non-muscle invasive bladder cancer (low or intermediate European Association of Urology risk)
- Non-muscle invasive bladder cancer requiring transurethral resection of bladder tumors (TURBT)
- Negative urine cytology for high-grade disease within 8 weeks before screening
- No lymph node or distant metastasis
- Use of effective contraception during the study and for at least 6 months after treatment for male and female patients
- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
- Willing and able to provide informed consent
You will not qualify if you...
- Tumors suspected to be high-grade
- Positive high-grade cytology
- Tumor diameter greater than 15 mm
- More than 5 bladder lesions
- Any intravesical therapy within the past year
- History of high-grade non-muscle invasive bladder cancer within the last 3 years
- Past or current muscle invasive bladder cancer or metastatic urothelial carcinoma
- History of upper tract urothelial carcinoma
- Clinically significant urethral stricture preventing catheter passage
- History of neurogenic bladder, active urinary retention, or conditions prohibiting normal voiding
- Active urinary tract infection not resolved prior to biopsy or treatment
- Refusal to participate
- Known positive HIV test
- Pregnant or breastfeeding females
- Female patients of childbearing potential not using adequate contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Urology, Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
E
Ekaterina Laukhtina Dr., Medical Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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