Bladder Cancer
Conditions
Keywords
bladder cancer, recurrence, photodynamic diagnosis, PDD, cost analysis
Brief summary
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.
Interventions
PROCEDUREwhite light TUR-BT
traditional transurethral bladder tumor resection
PROCEDUREblue light TUR-BT
photodynamic transurethral bladder tumor resection
DRUGoptimized MMC
six weekly optimized mitomycin-C instillations
DRUGsingle immediate chemotherapy instillation
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
Sponsors
Finnbladder
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
\- Primary papillary bladder cancer at high risk for further recurrence as defined as follows: Number of primary tumors ≥2, OR Size of solitary primary tumor ≥ 3 cm, OR Recurrent papillary tumors * Histologically proven Ta bladder cancer * Histological grade 1-2 (WHO 1973 grading system) or papillary urothelial neoplasm of low malignant potential (PUNLMP) or low grade (WHO 2004 grading system) bladder cancer * Written informed consent is required from every eligible patient
Exclusion criteria
* Grade 3 tumors (WHO 1973 grading system), or high grade tumors (WHO 2004 grading system) * CIS (carcinoma in situ) * Suspicion or evidence of papillary tumors or CIS of the upper urinary tract * Non-TCC (transitional cell carcinoma, i.e. urothelial carcinoma) bladder cancer * Suspicion or previous history of the patient not tolerating intravesical instillations * Known allergy to MMC or hexaminolevulinate (HAL, Hexvix®) * Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may compromise study participation (as judged by treating physician) * Pregnancy or lactating patient * Other non-cured malignancy (excepting skin basalioma or cancer in situ of the cervix uteri or any other malignancy in remission ≥5 years) * Age \< 18 years * Expected survival time less than one year * Expected poor compliance (e.g. some severe psychiatric disorders, antisocial behaviour, or dementia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bladder cancer recurrence rate | 2 years | any bladder cancer recurrence at 2 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bladder cancer progression | 2 years | bladder cancer progression to T2 or higher |
| Treatment failure | 2 years | progression, recurrence or side effects preventing completing the trial |
| mortality | 2 years | death due bladder cancer or other reasons |
Other
| Measure | Time frame | Description |
|---|---|---|
| costs | 2 years | For analysis of cost-effectiveness. All bladder cancer treatment and treatment complications related costs are included. |
Countries
Finland
Outcome results
None listed