Ongoing Clinical Trials for Bladder Transitional Cell Carcinoma Stage 0
There is currently 1 ongoing clinical trial for patients with Bladder Transitional Cell Carcinoma Stage 0, a type of non-muscle invasive bladder cancer where cancerous cells are present in the bladder lining but have not spread into the muscle layer. This trial is investigating an improved surgical approach using a light-sensitive drug to help surgeons see and remove tumors more effectively, with the goal of reducing the need for repeat surgeries.
Clinical trial locations
Study on Hexaminolevulinate for Patients with Non-Muscle Invasive Bladder Cancer to Reduce Need for Second Surgery
This trial is examining whether a specialized surgical technique called Photodynamic Trans-urethral Resection of Bladder Tumors (PDD-TURBT) can help patients avoid a second surgery while maintaining the same level of safety and effectiveness as the standard approach. The study is taking place in Italy and is expected to conclude by July 2027.
Main inclusion criteria:
- Patients must be at least 18 years old, male or female
- Clinical suspicion of primary or recurrent bladder cancer with recommendation for TURBT procedure
- Confirmed diagnosis of Non-Muscle Invasive Bladder Cancer (NMIBC) requiring a second look and resection according to European Association of Urology Guidelines
- Cancer must be limited to certain types: CIS, Ta, T1, N0, and M0, with no imaging evidence of muscle-invasive, locally advanced, or metastatic disease
- Patients must not have previously received BCG immunotherapy (BCG naïve)
- Must be physically fit to undergo all study procedures
- Ability to provide written informed consent
Main exclusion criteria:
- Having a different type of bladder cancer that is not NMIBC
- Being outside the specified age range
- Belonging to a vulnerable population requiring special protection or care
- Not meeting other specific health criteria required for the study
Focus and goal of the trial:
The trial compares two surgical approaches for removing bladder tumors. The first uses PDD-TURBT with a light-sensitive drug called Hexvix (hexaminolevulinate) that helps doctors see cancerous tissue more clearly during surgery. The second is the conventional white-light approach followed by a second surgery if needed. Researchers want to determine if the PDD-TURBT method can eliminate the need for a second procedure without increasing the risk of cancer returning.
Participants are randomly assigned to one of the two surgical methods. After surgery, they undergo regular follow-up checks, with the first examination at 3 months to check for early recurrence, and additional monitoring at 4.5 months to watch for late recurrences and disease progression. Throughout the study, researchers compare how often cancer returns, the time until any recurrence, and the overall health and quality of life of participants. The study also evaluates the cost-effectiveness of each approach.
Investigational drugs and procedures:
The main treatment being investigated is Hexvix (hexaminolevulinate), a light-sensitive drug administered directly into the bladder as an intravesical solution. When combined with a special light source during the PDD-TURBT procedure, it makes cancerous tissues more visible to surgeons, potentially improving the accuracy of tumor removal. The drug works through a mechanism called photodynamic therapy, where the light activates the drug to produce reactive oxygen species that damage and kill cancer cells.
The trial also examines conventional white-light TURBT and repeated TURBT (Re-TURBT) as comparison methods. Re-TURBT is a follow-up surgical procedure performed after the initial tumor removal to ensure any remaining cancerous tissue is removed, reducing the risk of recurrence.
Summary
Currently, there is one clinical trial available for patients with Bladder Transitional Cell Carcinoma Stage 0, located in Italy. This trial focuses on an innovative surgical approach using photodynamic diagnosis with hexaminolevulinate to potentially improve tumor removal accuracy and reduce the burden of repeat surgeries for patients with non-muscle invasive bladder cancer. The study represents an important effort to refine surgical techniques for early-stage bladder cancer, with the goal of improving patient outcomes while potentially reducing treatment costs and the need for multiple procedures. Patients interested in participating should meet specific criteria, including being BCG naïve and having confirmed NMIBC eligible for second-look resection.