Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9)

Treatment of Ta Bladder Cancer in High Risk of Recurrence - Fluorescence Cystoscopy With Optimized Adjuvant Mitomycin-C (FinnBladder 9)

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 Overview

• Status: Active, not recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: blue light TUR-BT; Drug: single immediate chemotherapy instillation; Procedure: white light TUR-BT; Drug: optimized MMC

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • HYKS Peijas Hospital
  • Hyvinkää, Finland
    • Hyvinkää District Hospital
  • Kuopio, Finland
    • Kuopio University Hospital
  • Mikkeli, Finland
    • Mikkeli Central Hospital
  • Oulu, Finland
    • Oulu University Hospital
  • Pori, Finland
    • Satakunnan Keskussairaala
  • Seinäjoki, Finland
    • Seinäjoki Central Hospital
  • Tampere, Finland
    • Tampere University Hospital
  • Tampere, Finland
    • Hatanpään sairaala
  • Turku, Finland
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group B; Blue light TUR-BT with no adjuvant instillations	Procedure: blue light TUR-BT; photodynamic transurethral bladder tumor resection; Drug: single immediate chemotherapy instillation; single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation; Other Names: single instillation
Active Comparator: Group A; White light TUR-BT with no adjuvant instillations	Drug: single immediate chemotherapy instillation; single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation; Other Names: single instillation; Procedure: white light TUR-BT; traditional transurethral bladder tumor resection
Experimental: Group C; White light TUR-BT with six weekly optimized mitomycin-C instillations.	Drug: single immediate chemotherapy instillation; single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation; Other Names: single instillation; Drug: optimized MMC; six weekly optimized mitomycin-C instillations; Other Names: optimized mitomycin-C
Experimental: Group D; Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.	Procedure: blue light TUR-BT; photodynamic transurethral bladder tumor resection; Drug: single immediate chemotherapy instillation; single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation; Other Names: single instillation; Drug: optimized MMC; six weekly optimized mitomycin-C instillations; Other Names: optimized mitomycin-C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bladder cancer recurrence rate	any bladder cancer recurrence at 2 years.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder cancer progression	bladder cancer progression to T2 or higher	2 years
Treatment failure	progression, recurrence or side effects preventing completing the trial	2 years
mortality	death due bladder cancer or other reasons	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
costs	For analysis of cost-effectiveness. All bladder cancer treatment and treatment complications related costs are included.	2 years

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: Finnbladder
• Investigators: Principal Investigator: Peter J. Boström, MD, PhD, Turku University Hospital; Study Director: Eero Kaasinen, Md, PhD, Hyvinkää District Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2021
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: August 25, 2012
• First Submitted That Met QC Criteria: August 28, 2012
• First Posted (Estimate): August 29, 2012

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: bladder cancer; recurrence; cost analysis; PDD; photodynamic diagnosis
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin
• Other Study ID Numbers: FinnBladder 9; 2012-000559-15 (EudraCT Number)