Carcinoma of Urinary Bladder, Superficial Clinical Trial
Official title:
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)
In the proposed study the investigators aim to evaluate the effect of the standard of care
dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low
risk recurrent NMIBC lesions and to compare our findings to instillation with the standard
mode of instillation- 40mg MMC in water in order to examine our hypothesis that MMC mixed
with TC-3 gel will have at least non-inferior and even superior results over the standard
instillation mode
The investigators believe that this study is of importance of 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 of 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 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, which might improve the patient's prognostic outcome.
5. If this experimental treatment will prove to have a better ablative effect, this could
be translated to a better prophylactic effect of tumor recurrence.
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 as Mitomycin C (MMC) or BCG. This treatment approach is limited due
to rapid dilution the chemotheraputic drug by the incoming urine and clearance by urination.
TheraCoat core technology is based on a reverse thermal biodegradable gel (TC-3) (low
viscosity at 5°C gel appearance at body temperature)for drug retention in the urinary
bladder.
Prior to instillation, the TC-3 hydrogel, in a liquid state, is mixed with MMC.TC-3 mixed
with MMC is instilled to the bladder by a catheter. Following gel insertion to the bladder,
the gel solidifies and forms a drug reservoir inside the bladder. Upon contact with urine
the gel dissolves and is cleared out from the bladder.
Intravesical MMC instillation using TheraCoat 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 the Baseline status and after that a follow-up period: 3,6,9,12
months.
;
| Status | Clinical Trial | Phase | |
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