Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer
A multi-center, open-label, phase II clinical study of metformin in up to evaluable 49 patients with low-grade NMIBC with the aim to determine the overall response to administration of oral metformin for 3 months in a index papillary NMIBC tumour.
• Age \> 18 years.
• Patients with primary or recurrent suspectedTa or T1, G1 or G2 (low grade) urothelial carcinoma of the bladder with no suspicion of carcinoma in situ.
• Patients must have at least 1 lesion but no more than 5.
• There must be one index lesion measuring between 0.5 and 1.0 cm in its greatest dimension.
• Bimanual examination immediately following cystoscopyshould be carried out and no mass should be felt.
• Adequate renal function (eGFR \>50 ml/min/1.73m2 according to CKD-EPI). (47)
• Adequate liver function (bilirubin \<1.5 times upper limit of normal, ALAT or ASAT \<2.5 the upper limit of normal).
• Eligible patients must be fully informed of the investigational nature of the study and written signed informed consent must be obtained prior to any study specific investigations.
• Mentally, physically, and geographically able to undergo treatment and follow up.