Bladder cancer (BC), the second most common urological malignancy, is an important public health issue. One of the main challenges in the treatment of bladder cancer if the prevention of recurrences of non-invasive tumors, which is also associated with significant costs. The current study will investigate optimal treatment of patients with bladder cancer with high risk of tumor recurrence but low risk of progression. The main interest is comparison of photodynamic (PDD) bladder tumor resection (TUR-BR)to traditional TUR-BT. Also the efficacy of adjuvant optimized mitomycin-C is compared to patients with no adjuvant treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
traditional transurethral bladder tumor resection
photodynamic transurethral bladder tumor resection
six weekly optimized mitomycin-C instillations
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
HYKS Peijas Hospital
Helsinki, Finland
Hyvinkää District Hospital
Hyvinkää, Finland
Kuopio University Hospital
Kuopio, Finland
Mikkeli Central Hospital
Mikkeli, Finland
Oulu University Hospital
Oulu, Finland
Satakunnan keskussairaala
Pori, Finland
Seinäjoki Central Hospital
Seinäjoki, Finland
Hatanpään sairaala
Tampere, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
bladder cancer recurrence rate
any bladder cancer recurrence at 2 years.
Time frame: 2 years
Bladder cancer progression
bladder cancer progression to T2 or higher
Time frame: 2 years
Treatment failure
progression, recurrence or side effects preventing completing the trial
Time frame: 2 years
mortality
death due bladder cancer or other reasons
Time frame: 2 years
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