Active not recruitingNAINTERVENTIONAL

Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression

Doctors are studying whether certain changes can help slow down or stop low-risk prostate cancer from growing. This study is testing two approaches: a special diet high in healthy omega-3 fats and low in unhealthy fats, and a medication called dutasteride. Participants will try one of these methods for six months, then use both together for another six months. The aim is to understand how these treatments, alone and combined, affect prostate cancer. This research could help doctors find better ways to manage low-risk prostate cancer in the future.

At a glance

Status

Active not recruiting

Phase

Sponsor

CHU de Quebec-Universite Laval

Enrolment target

120

Start

28 Oct 2010

Estimated completion

01 Dec 2026

Prostatic Neoplasms Low Grade Prostate Cancer

What is this study about?

This research study is looking into ways to manage low-risk prostate cancer. You might have been told you have a type of prostate cancer that isn't immediately dangerous and is being watched carefully, often called 'active surveillance.' This study aims to see if making certain dietary changes or taking a specific medication can help stop this low-risk cancer from getting worse.

The researchers want to understand how two things might work: first, a diet that focuses on marine omega-3 fatty acids (the healthy fats found in some fish) while reducing less healthy fats, and second, a medication called dutasteride. They are trying to figure out if either of these, or a combination of both, can be effective in preventing the cancer from progressing.

By taking part, you would be helping doctors learn more about managing low-risk prostate cancer without needing more aggressive treatments immediately. This could lead to new ways of helping men in the future.

Key takeaways

Study examines diet and medication for low-risk prostate cancer.
Participation involves diet changes, drug use, and some medical tests.
The study lasts for 12 months in total.
Aims to find new ways to prevent cancer progression.
Open to men aged 35 to 75 with low-risk prostate cancer.
You can stop participating at any time.

Who may be eligible?

To be able to join this study, you would need to be a man between 35 and 75 years old.

You must have been diagnosed with a low-risk type of prostate cancer that your doctor believes is suitable for 'active surveillance.' This means your doctor is currently watching your cancer closely rather than treating it straight away.

There are a few reasons why you might not be able to join. For example, if you are currently taking fish oil supplements or certain anti-inflammatory drugs called NSAIDs, you wouldn't be able to participate. It's also important that you are willing and able to give your informed consent, meaning you understand the study and agree 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 a man between 35 and 75 years old?
Do you have low-risk prostate cancer that your doctor is currently 'watching'?
Are you not currently taking fish oil supplements?
Are you not currently taking NSAID pain relievers (like ibuprofen or naproxen) regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for a year. For the first six months, you would either follow a special diet (rich in certain healthy fats and low in unhealthy ones) or take the dutasteride medication. Which one you start with would be decided at the beginning.

After these first six months, everyone in the study would then use both the special diet and the dutasteride medication for the remaining six months to complete the full year. Throughout the study, you would have three prostate biopsies: one when you start, another after 6 months, and the final one at 12 months. Each time you have a biopsy, blood samples would also be collected, and you would provide a urine sample before and after a digital rectal exam.

Potential risks and benefits

Taking part in this study could potentially help scientists understand better ways to manage low-risk prostate cancer, which might benefit you and others in the future. However, there are potential risks, such as those associated with prostate biopsies (like discomfort or small risks of infection), blood draws, and potential side effects from the medication or diet changes. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Hotel-Dieu of Quebec
Verified postcode
Québec, Canada
Institute of nutraceuticals and functional food of Laval University
Verified postcode
Québec, Canada

Common questions

What is low-risk prostate cancer?

It's a type of prostate cancer that doctors believe is growing very slowly and may not need treatment right away, often just careful monitoring.

What are omega-3 fatty acids?

These are healthy fats often found in fish, which are good for your health. The study uses a diet rich in these.

What is dutasteride?

Dutasteride is a medicine that works to reduce certain hormones in the body, which can affect the prostate gland.

Will I know which treatment I'm on?

Yes, you would know if you are starting with the diet or the medication, and after six months, everyone uses both.

How often will I need to visit the hospital?

You would have three main visits for biopsies, blood tests, and urine samples at the start, 6 months, and 12 months.