Non Muscle Invasive Bladder Cancer Clinical Trial
Official title:
A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC)
This study is a prospective randomized open labeled dose ranging comparative study. Twenty
four (24) patients with NMIBC who meet the inclusion/exclusion criteria will be recruited
for the study following the initial diagnostic cystoscopy.
The investigators believe that this study is of importance on several aspects:
1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the
current instillation mode.
2. If proved effective, this mode of treatment might save the need for TURBT performance
and serve as a new mode of tumor ablation.
3. Even if proved partially effective, this mode of treatment will diminish tumors size
and/or number, thus enable a more limited TURBT procedure.
4. This mode of treatment will enable immediate medical attendance to the patient's tumor
recurrence without the waiting period (resulting from queues in the medical centers)
for TURBT. This might improve the patient's prognostic outcome.
5. If this experimental treatment will prove to have a better ablative effect in
comparison to the standard of care known in the art, this could be translated to a
better prophylactic effect of tumor recurrence.
6. Finding the minimal, yet optimal, effective dose for tumor ablation and tumor
recurrence prevention will enable us to reduce adverse effects of higher drug dosage.
Non-muscle-Invasive Bladder cancer is mainly treated by tumor resection (Trans Urethral
Resection - TUR), followed by series of intravesical instillations of prophylactic
chemotherapeutic drugs such as Mitomycin C (MMC) or BCG. Unfortunately, this treatment
approach is limited due to rapid dilution of the chemotherapeutic drug by the incoming urine
and clearance by urination.
TheraCoat's core technology is based on a reverse thermal biodegradable gel (TC-3 Gel) (low
viscosity at cold temperature (5°C) and gel appearance at body temperature)for drug
retention in the urinary bladder.
Prior to instillation, the TC-3 Gel, in its liquid state, is mixed with MMC and instilled
into the bladder by a standard catheter. Once inside the bladder, the gel solidifies and
forms a drug reservoir. Upon contact with urine, the gel dissolves, release the drug slowly
and is finally cleared out from the bladder.
Intravesical MMC instillation using TheraCoat's gel is expected to increase treatment
efficiency due to prolongation of treatment duration and consequently improving bladder
exposure to MMC.
Treatment Protocol - Immediately following baseline cystoscopy and tumor diagnosis and
patient undergoes 6 weekly instillations followed by 2-4 weeks healing period.
1st Follow-Up Visit (Pre-Scheduled TURBT Visit): The patient will undergo a second
cystoscopy to compare to baseline status. The patient will be followed-up for a period of 1
year as follows: 3,6,9,12 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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