RecruitingPHASE2INTERVENTIONAL

Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer

This study is investigating if a medicine called dutasteride can help prevent low-grade, non-muscle-invasive bladder cancer (NMIBC) from returning. This type of bladder cancer often comes back after treatment, which can lead to more operations and affect a person's quality of life. Currently, there isn't a routine preventative treatment for this type of cancer that is both effective and easy to use. Dutasteride is a tablet taken by mouth that is generally well-tolerated. The study hopes to find out if this medicine can offer a simple way to reduce the chance of the cancer coming back, as well as checking its safety in women. We continually want to find effective options that improve outcomes for patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Paul Toren

Enrolment target

Start

25 Mar 2026

Estimated completion

02 Apr 2032

Bladder Cancer

What is this study about?

This study is focused on a common type of bladder cancer called low-grade, non-muscle-invasive bladder cancer. While treatments for this condition are available, the cancer often tends to come back. When it recurs, it means more hospital visits and procedures for patients, which can be disruptive and stressful. Finding a way to prevent these recurrences could significantly improve the lives of many people.

Currently, there isn't a widely used and well-tolerated preventive medicine for this specific type of bladder cancer. This research aims to see if an existing medicine called dutasteride could fill this gap. Dutasteride works by blocking certain hormones in the body. It's already known to be generally well-tolerated and is taken as a simple tablet.

The main goal of this research is to discover if dutasteride can effectively reduce the risk of this bladder cancer returning. The study will also carefully check for any side effects and see how safe it is for both men and women to take. Ultimately, the hope is to find a straightforward and effective way to help patients avoid repeated cancer recurrences.

Key takeaways

This study explores a new way to prevent bladder cancer from returning.
It tests an existing medicine called dutasteride for low-grade bladder cancer.
Participation involves taking a daily tablet and regular check-ups for up to two years.
The study aims to improve quality of life by reducing cancer recurrences.
It includes both men and women to understand safety and effectiveness broadly.

Who may be eligible?

To join this study, you need to be aged 18 or older and have a confirmed diagnosis of low-grade, non-muscle-invasive bladder cancer. This means your cancer hasn't grown into the bladder muscle and is considered a less aggressive type. You also should not have been recommended for certain other bladder cancer treatments, like BCG or powerful chemotherapy injections into the bladder, as your main treatment recently.

There are also some reasons why you might not be able to join. For example, if you've recently had or are scheduled for BCG treatment or powerful bladder chemotherapy. Also, if you have certain other medical conditions like severe liver problems, unstable heart conditions, or other cancers treated with hormone therapy, you might not be suitable. Women who are pregnant or planning to become pregnant, or men planning to father children, would have specific discussions with the study team about contraception due to the medication.

If you've previously had a severe allergic reaction to dutasteride or a similar drug called finasteride, you wouldn't be able to participate. The study team will review all your medical information carefully to make sure it's safe for you to take part.

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 18 years old or older?
Have you been diagnosed with low-grade, non-muscle-invasive bladder cancer?
Have you NOT been recently recommended for BCG or certain strong bladder chemotherapy?
Are you able to take a daily tablet and attend regular appointments?
Do you have a severe allergy to dutasteride or finasteride?

Answer every question to see your result.

What does participation involve?

If you decide to join this study and are found to be suitable, you will take a medicine called dutasteride, a 0.5 mg tablet, once every day. You'll continue taking this medicine until your bladder cancer recurs or for a maximum of two years, whichever comes first. If your cancer does come back within this period, you might still be able to continue the dutasteride treatment for up to the full two years, with the decision made in discussion with your doctor.

During the study, you will have regular check-ups to monitor your health, how you are responding to the treatment, and to check for any side effects. This will involve appointments at the clinic and potentially some tests. The study team will carefully explain the schedule of these appointments and what each one involves. The full duration of your participation could be up to two years, depending on your individual response.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of reducing the chance of your bladder cancer recurring, meaning fewer procedures and less anxiety. However, it's important to remember that this is a research study, and we don't yet know for sure if dutasteride will be effective for this condition. As with any medication, there can be potential risks and side effects. The study team will thoroughly explain all known or potential side effects of dutasteride before you agree to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CHU de Québec - Université Laval
Verified postcode
Québec, Canada· Recruiting

Common questions

What kind of bladder cancer is this study for?

This study is for people with low-grade, non-muscle-invasive bladder cancer, which means the cancer hasn't spread into the bladder muscle.

What is dutasteride, and how do I take it?

Dutasteride is a tablet that you would take once a day by mouth. It aims to block certain hormones in the body.

How long will I be in the study?

You could be in the study for up to two years, or until your cancer returns, whichever happens first.

Is this medicine new?

Dutasteride is an existing medicine, but its use for preventing bladder cancer recurrence in this specific way is being studied.

What if the cancer comes back while I'm on the study?

If your cancer returns, you might be offered the option to continue taking dutasteride for up to two years, depending on discussions with your doctor.

How to find out more

Paul Toren Principal Investigator, MD

paul.toren@crchudequebec.ulaval.ca 418 525 4444 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.