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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying non-muscle invasive bladder cancer (NMIBC), a type of bladder cancer that has not spread into the muscle layer of the bladder. The study is comparing two different surgical methods for removing bladder tumors. One method uses a special technique called Photodynamic Trans-urethral Resection of Bladder Tumors (PDD-TURBT), which involves using a light-sensitive drug called Hexvix (hexaminolevulinate) to help doctors see and remove the cancer more clearly. The other method is the conventional approach using white light during surgery, followed by a second surgery if needed.

The purpose of the study is to see if the PDD-TURBT method can help avoid the need for a second surgery without increasing the risk of cancer coming back. Participants in the study will be randomly assigned to one of the two surgical methods. After the surgery, they will be monitored for any signs of cancer returning, with follow-up checks scheduled over several months. The study aims to provide evidence on whether the new method can be as effective as the standard approach while potentially reducing the need for additional surgeries.

Throughout the study, researchers will compare the outcomes of patients who undergo the PDD-TURBT method with those who have the conventional surgery. They will look at how often the cancer returns, the time it takes for any recurrence, and the overall health and quality of life of the participants. The study will also assess the costs associated with each method to determine if the new approach could be more cost-effective in the long run. The findings from this study could help improve treatment guidelines for patients with NMIBC.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis, and previous treatments.
Written informed consent is required to participate in the trial.
Step 2
Initial procedure
The trial involves a procedure called Trans-urethral Resection of Bladder Tumor (TURBT), which is a surgical method to remove bladder tumors.
The procedure is performed using a special technique called Photodynamic Diagnosis (PDD), which helps in identifying cancerous tissues more effectively.
Step 3
Medication administration
A medication named Hexvix is used during the procedure. It is administered as an intravesical solution, meaning it is introduced directly into the bladder.
The active substance in Hexvix is hexaminolevulinate, which helps in enhancing the visibility of cancerous tissues during the procedure.
Step 4
Follow-up and monitoring
After the initial procedure, follow-up cystoscopy is scheduled to monitor for any recurrence of bladder cancer.
The first follow-up occurs at 3 months to check for early recurrence of cancer.
Step 5
Further follow-up
Additional follow-ups are conducted after 4.5 months to monitor for late recurrences and progression of the disease.
The trial aims to compare the outcomes of this new approach with the standard treatment, which involves a second surgical procedure if necessary.
Step 6
End of trial
The trial is expected to conclude by July 31, 2027.
Throughout the trial, various health and quality of life assessments are conducted to evaluate the effectiveness and impact of the treatment.

Who can join the trial?

7 criteria

Patients must be at least 18 years old and can be either female or male.
Patients should have a clinical suspicion of primary or recurrent **bladder cancer** and have been advised to undergo a procedure called **TURBT** (Trans-Urethral Resection of Bladder Tumor).
Patients must have a confirmed diagnosis of **Non-Muscle Invasive Bladder Cancer (NMIBC)** and be candidates for a second look and resection, as per the European Association of Urology (EAU) Guidelines.
There should be no imaging evidence of more serious conditions like muscle-invasive, locally advanced, or metastatic bladder cancer. Only certain types of bladder cancer, such as **CIS**, **Ta**, **T1**, **N0**, and **M0**, are eligible.
Patients should not have received a specific type of treatment called **BCG immunotherapy** for any previous bladder cancer history. This means they are **BCG naïve**.
Patients must be fit to undergo all the procedures listed in the study protocol.
Patients must be able to provide written informed consent, which means they understand the study and agree to participate.

Who cannot join the trial?

4 criteria

Patients who have a different type of bladder cancer that is not Non-muscle invasive bladder cancer (NMIBC).
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.
Patients who do not meet other specific health criteria required for the study.

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Universita Degli Studi Di Roma La Sapienza
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Rome, Italy

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Investigated drugs

Photodynamic Trans-urethral Resection of Bladder Tumors (PDD-TURBT)
is a surgical procedure used to remove bladder tumors. This method uses a special light-sensitive drug and a light source to help surgeons see and remove cancerous tissues more effectively. It aims to improve the accuracy of tumor removal and reduce the need for additional surgeries.
Conventional White-light Trans-urethral Resection of Bladder Tumors (TURBT)
is a standard surgical technique for removing bladder tumors. It involves using a white light to guide the surgeon in removing the tumor. This method is commonly used but may require a follow-up surgery to ensure all cancerous tissue is removed.
Repeated Trans-urethral Resection of Bladder Tumors (Re-TURBT)
is a follow-up surgical procedure performed after the initial tumor removal. It is used to ensure that any remaining cancerous tissue is removed, reducing the risk of cancer recurrence. This procedure is part of the standard care for certain bladder cancer patients.

Hexaminolevulinate

What is already known about the treatment

Photodynamic Therapy (PDT) – This treatment is administered through a procedure called photodynamic trans-urethral resection of bladder tumors (PDD-TURBT), which involves using a light-sensitive drug and a light source to target and destroy cancer cells in the bladder. Currently, it is being studied in clinical trials for its effectiveness in treating non-muscle invasive bladder cancer (NMIBC) and is considered an innovative approach in medical literature. The main therapeutic indication is for patients with NMIBC, aiming to reduce the need for additional surgical procedures. At the molecular level, the mechanism of action involves the activation of the photosensitizing agent by light, which produces reactive oxygen species that damage and kill cancer cells. This therapy falls under the pharmacological classification of photodynamic therapy, which is a type of targeted cancer treatment.

Investigated diseases

Non-muscle invasive bladder cancer (NMIBC) – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not yet invaded the muscle layer of the bladder. It is often detected at an early stage and can vary in aggressiveness. The disease may present with symptoms such as blood in the urine, frequent urination, or pain during urination. NMIBC is typically managed with procedures like transurethral resection of bladder tumor (TURBT) to remove the tumor. The progression of NMIBC can involve recurrence of tumors in the bladder lining, which may require additional treatments. Monitoring and follow-up are crucial to manage and detect any recurrence or progression of the disease.