Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Intravesical Mistletoe Extract in Superficial Bladder Cancer: A Phase III Efficacy Study

This study is investigating a new treatment for people with a common type of bladder cancer that has been removed by surgery. It's called 'Intravesical Mistletoe Extract' and uses a special mistletoe solution put directly into the bladder. The main aim is to see if this mistletoe treatment can stop the cancer from returning for a longer time compared to current treatments. Researchers will also be checking for any side effects and how it affects patients' quality of life. This is a Phase III study, which means it's one of the final steps before a new treatment might become widely available, showing doctors are confident in its potential. Participants will have had their bladder cancer completely removed and will have specific types of early-stage cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Abnoba GmbH

Enrolment target

522

Start

28 Jun 2023

What is this study about?

This study is specifically looking at a type of bladder cancer which is found early and has not spread deeply into the bladder wall. After surgery to remove these early-stage tumours, patients often receive medication directly into their bladder to help prevent the cancer from coming back. This study is testing if a treatment based on mistletoe extract, called abnobaVISCUM Fraxini, is better at stopping the cancer from returning compared to the standard medications (Mitomycin or Epirubicin) currently used.

The main thing doctors want to find out is how long it takes for the cancer to come back, if it does at all. They will be carefully tracking this for all patients in the study. If a patient's cancer does return, they will stop receiving the study treatment and discuss further options with their medical team. This helps ensure that patients are always getting the most appropriate care.

Alongside checking how well the treatment works, the study will closely monitor patient safety. This means keeping a close eye on any side effects or discomfort. Researchers will also look at how patients feel generally and their quality of life, using special questionnaires. The goal is to provide a better understanding of treatments for bladder cancer, potentially offering a new option that helps more people stay cancer-free for longer.

Key takeaways

This study is testing a mistletoe extract for early-stage bladder cancer.
It aims to see if it can stop cancer from returning longer than current treatments.
The treatment is given directly into the bladder.
Researchers will check how well it works and if it's safe.
It's for people whose early-stage bladder cancer was fully removed.

Who may be eligible?

This study is for adults, both men and women, between the ages of 18 and 85 years old. To join, your bladder cancer must have been surgically removed completely, and it needs to be a specific type of early-stage cancer often described as 'superficial' or 'Ta tumours'.

Your cancer must be considered 'intermediate-risk' by the doctors, and you shouldn't have more advanced stages of cancer like 'CIS' or 'G3 tumours'. Also, after your surgery, you must have already received one dose of standard medication (Mitomycin or Epirubicin) into your bladder.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 85 years old?
Has your very early-stage bladder cancer (Ta tumour) been completely removed?
Is your cancer considered 'intermediate-risk' by your doctor?
Do you not have more advanced types of bladder cancer (like CIS or G3 tumours)?
Have you already received one dose of standard treatment (like Mitomycin) into your bladder after surgery?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the mistletoe extract treatment or one of the standard treatments, put directly into your bladder. The main thing that will be checked is how long it takes for your cancer to return. You will have regular check-ups, which include blood tests, urine tests, and answering questionnaires about how you are feeling and your quality of life. Researchers will also monitor very carefully for any side effects. If your cancer comes back, you will stop the study treatment. The total duration of your participation will depend on how your treatment progresses, but you'll be monitored closely throughout.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment option that might be more effective at preventing your bladder cancer from returning compared to current standard treatments. However, as with any medical treatment, there's a chance of side effects, which will be carefully monitored by the medical team. There is also the possibility that the mistletoe extract might not work better than existing treatments. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is 'superficial bladder cancer'?

This is a type of bladder cancer that has only grown on the inner lining of the bladder and has not spread deeper into the bladder wall.

What does 'intravesical' mean?

It means the treatment is given directly into your bladder, usually through a small tube called a catheter.

What is mistletoe extract?

It's a substance made from the mistletoe plant, which is being studied for its potential effects in various medical conditions, including cancer.

Why is this a 'Phase III' study?

A Phase III study is a large study that compares a new treatment to existing ones to confirm if it's better and safe enough to be approved for wider use.

What does 'time to tumour recurrence' mean?

This is the length of time from when you start the study until your cancer comes back, if it does. It's a way scientists measure how well a treatment works.