RecruitingPhase 2/3

Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma

Canada70 participantsStarted 2024-06-19

Plain-language summary

The goal of this prospective clinical trial is to investigate the safety and efficacy of ST-02 (mucoadhesive gemcitabine suspension for pyelocaliceal instillation) to treat Upper Tract Urothelial Carcinoma (UTUC) in participants who have a low-grade tumor. The main questions this study aims to answer are: 1. Can ST-02 effectively eradicate UTUC by 3 months? 2. Is ST-02 safe for patients with UTUC? Participants in this study will receive ST-02, a new formulation with gemcitabine once weekly for six weeks. Gemcitabine is known to be an effective drug in treating urothelial carcinoma. This new formulation will be instilled directly into the upper urinary tract (renal pelvis) and will allow the chemotherapeutic to work locally for an extended period of time. The administration process will be retrograde (via a small catheter inserted up into the kidney, under anesthesia) or antegrade (via a nephrostomy, in the clinic) once weekly for six weeks. Safety and efficacy will be monitored for up to a year after the initial response assessment.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult (≥ 18 years) male or female * Primary or recurrent low-grade (LG), noninvasive (Ta) Upper Tract Urothelial Carcinoma (UTUC) in the renal pelvis, infundibulum, and/or calyces, based on ureteroscopy, biopsy and cytology (disease assessment URS) performed within 8 weeks prior to or during the Screening Visit * At least 1 measurable papillary tumor measuring 5-15 mm * Low grade tumor(s) in the ipsilateral ureter. Every attempt should be made to ablate this tumor completely, but residual ipsilateral ureteral tumor is not an exclusion criterion. * Prior fully ablated low grade bladder tumor(s), without the need for intravesical therapy except for single-dose chemotherapy * A life expectancy of greater than 12 months * No active untreated urinary tract infection (UTI) as confirmed by urine culture or urinalysis * Women of Child bearing potential (WoCBP) and Males who have a WoCBP partner require a negative pregnancy test at the Screening visit and must use two acceptable contraceptives methods until six months post-treatment * All sexually active males must agree to use a condom during intercourse, for at least 48 h after each instillation * eGFR ≥10 mL/min; weekly creatinine monitoring recommended during treatment for participants with eGFR \<30 mL/min or a solitary functional kidney Exclusion Criteria: * Have received Bacillus Calmette - Guerin (BCG) treatment for UTUC within 6 weeks prior to Visit 1 (D1) * Pregnant (positive urine pregnancy test), p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete Response (CR) rate at the Primary Tumor Evaluation (PTE) visit

Timeframe: 3 months

Trial details

NCT IDNCT06124976

SponsorPeter Black

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04

Contact for this trial

Dasa Durkotova

236 869 3437 ddurkotova@prostatecentre.com

View on ClinicalTrials.gov More Urothelial Carcinoma of the Renal Pelvis and Ureter trials