A consecutive series of patients with High Risk Non-Muscle Invasive Bladder Cancer will be
enrolled in several centres. The subjects will be assessed for eligibility at the screening
visit (Visit 1) three weeks after Trans-Urethral Resection of the Bladder (TURB) and re-TURB
prior to randomization and only subjects who fulfil the inclusion criteria will be included.
Patients selected for the study, are centrally randomized (randomization is performed at the
Sant'Andrea Hospital) to receive BCG induction treatment according to the standard protocol
(an instillation once a week for six weeks) with Immucyst (81 mg Connaught strain BCG).
Patients in group two received BCG treatment with the same protocol with a 40 mg mitomycin
instillation the day before .