Transitional cell carcinoma recurrent Trials in Disease

Study on Hexaminolevulinate for Patients with Non-Muscle Invasive Bladder Cancer to Reduce Need for Second Surgery

This clinical trial is investigating whether a special surgical technique can help patients with non-muscle invasive bladder cancer avoid the need for a second surgery. The study is taking place in Italy and focuses on comparing two different methods for removing bladder tumors.

Main inclusion criteria:

• Adults aged 18 years or older, both male and female
• Clinical suspicion of primary or recurrent bladder cancer requiring TURBT (trans-urethral resection of bladder tumor)
• Confirmed diagnosis of non-muscle invasive bladder cancer, including CIS, Ta, T1, N0, and M0 types
• Candidates for a second look and resection according to European guidelines
• No previous BCG immunotherapy treatment
• Ability to undergo all study procedures and provide informed consent

Main exclusion criteria:

• Patients with other types of bladder cancer that are not non-muscle invasive
• Patients outside the specified age range
• Vulnerable populations requiring special protection
• Patients not meeting other specific health requirements

Study focus and goals:

The trial compares two surgical approaches for removing bladder tumors. The first method uses Photodynamic Trans-urethral Resection of Bladder Tumors (PDD-TURBT), which involves a light-sensitive drug called Hexvix (hexaminolevulinate) that helps doctors see cancerous tissue more clearly during surgery. The second method is the conventional approach using white light during surgery, followed by a second surgery if needed.

The main goal is to determine whether the PDD-TURBT method can effectively eliminate the need for a second surgery without increasing the risk of cancer returning. Patients will be randomly assigned to one of the two surgical methods and monitored carefully over several months with scheduled follow-up appointments.

After the initial procedure, patients will have their first follow-up cystoscopy at 3 months to check for early recurrence. Additional follow-ups occur at 4.5 months to monitor for late recurrences and disease progression. The trial is expected to conclude by July 31, 2027.

Investigational treatment:

The study uses Hexvix (hexaminolevulinate), a light-sensitive medication administered directly into the bladder before surgery. When exposed to a special light during the procedure, this drug causes cancerous tissues to glow, making them easier for surgeons to identify and remove completely. This photodynamic approach works at the molecular level by producing reactive oxygen species that damage and destroy cancer cells when activated by light.

Throughout the study, researchers will evaluate how often cancer returns, the time it takes for any recurrence, the overall health and quality of life of participants, and the costs associated with each method. The findings could help improve treatment guidelines for patients with non-muscle invasive bladder cancer.