Gemcitabine chemoablation for low-grade bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, prospective, open-label Phase 2 study that gives six weekly intravesical instillations of gemcitabine to adults with histologically confirmed Ta low-grade bladder cancer. Eligible participants may have up to five tumors with the largest lesion ≤15 mm and must have negative cytology for high-grade disease and no metastases. The protocol collects cystoscopic and cytologic outcomes to measure local tumor response and monitors safety and tolerability throughout follow-up. The approach aims to determine whether chemoablation can clear or control small low-grade lesions and potentially reduce the need for transurethral resection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male/female participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study
* Diagnosis of a recurrent tumor and a history of TaLG BCa or diagnosis of primary TaLG BCa histologically confirmed by cold cup biopsy at screening or within 8 weeks before screening
* On screening cystoscopy: Diameter of the largest lesion ≤15mm
* Number of lesions ≤5
* Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation
* Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk)
* NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT)
* Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening
* No lymph node metastasis or distant metastasis
* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Female patients of childbearing potential must use adequate contraception during study period
* Willing and able to provide informed consent

Exclusion Criteria:

* Tumors that clinicians suspect to be HG
* Positive HG cytology according to Paris criteria
* Diameter of tumor \>15 mm
* Number of lesions \>5
* Any previous intravesical therapy within 1 year
* Previous HG NMIBC (within the last 3 years). It is allowed to include patients who had history of HG disease longer than 3 years ago.
* Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC
* History of upper tract urothelial carcinoma (UTUC)
* Clinically significant urethral stricture that would preclude passage of a urethral catheter
* History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding
* Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment
* Patient refused to participate
* Known positive human immunodeficiency virus (HIV) test.
* Female patients who are pregnant/breastfeeding.
* Female patients of childbearing potential not using adequate contraception.

Where it's running

• Department of Urology, Medical University of Vienna
  Vienna, Austria Recruiting

Study contacts

• Principal investigator: Shahrokh F. Shariat Prof. Dr., Professor — Department of Urology, Medical University of Viernna
• Study coordinator: Ekaterina Laukhtina Dr., Medical Doctor
• Email: ekaterina.laukhtina@meduniwien.ac.at
• Phone: +43 (0)1 40400-26315

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.