Active not recruitingPHASE2INTERVENTIONAL

Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.

Prostate cancer can sometimes return after initial treatments like surgery or radiation. When this happens, doctors sometimes recommend a treatment called androgen deprivation therapy (ADT), but this can have significant side effects. This study aims to find out if a specific omega-3 fatty acid supplement, called MAG-EPA, can help delay the need for ADT in men whose prostate cancer has shown signs of coming back. Omega-3s are found in fish and have been suggested to have some benefits against prostate cancer. Researchers will give either the MAG-EPA supplement or a dummy pill (placebo) to 40 men for one year and watch for any effects. This is a small, early-stage study to see if a larger study would be worthwhile.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

CHU de Quebec-Universite Laval

Enrolment target

Start

10 Jul 2017

Estimated completion

01 Dec 2026

Prostate Cancer

What is this study about?

When men have prostate cancer, they often have treatments like surgery or radiotherapy. While these treatments are usually successful, in some cases, the cancer can show signs of returning later on. This is called 'biochemical recurrence' or 'progression' and is often detected by a rising level of a protein called PSA in the blood. If this happens, doctors and patients often look for ways to manage it that might delay other treatments, like hormone therapy (androgen deprivation therapy or ADT), which can have side effects.

This study is looking at an omega-3 supplement called MAG-EPA. Omega-3 fatty acids, which you find in foods like oily fish, have been studied for their potential health benefits, and some early research has hinted that they might have a positive effect on prostate cancer. The idea behind this study is that taking a daily omega-3 supplement might help slow down the return of prostate cancer or delay the need for hormone therapy, potentially avoiding or postponing its side effects. Omega-3s are also generally known for other health benefits, like helping with inflammation, which is a nice contrast to the possible side effects of hormone therapy.

This is a 'pilot' study, meaning it's a small, initial research project. They are recruiting 40 men to take either the MAG-EPA supplement or a placebo (a dummy pill) for one year. The results from this small study will help the researchers decide if there's enough evidence to conduct a much larger study in the future. If successful, this simple dietary supplement could offer a new way to help men manage their prostate cancer without some of the tougher side effects of other treatments.

Key takeaways

This study evaluates an omega-3 supplement (MAG-EPA) for prostate cancer recurrence.
It aims to delay the need for hormone therapy (ADT) and its side effects.
Participation involves taking a daily pill and regular check-ups for one year.
This is a small pilot study to see if a larger trial should be done.
You participate for 1 year, with regular medical checks.

Who may be eligible?

To be considered for this study, you must be a man aged between 18 and 100 with prostate cancer that has been confirmed by a doctor. Your prostate cancer must show signs of returning or progressing after you've already had a main treatment like surgery or radiotherapy. This is usually seen by your PSA blood level starting to rise again. Your PSA level also needs to be within a certain range to join the study.

It's important that your PSA level has been consistently going up over at least three recent blood tests. You might have had different local treatments for your prostate cancer in the past, and that's generally fine. You also need to be willing to give your written permission to take part in the study.

However, some things would mean you can't join. If your cancer has spread to other parts of your body, or if you've had certain chemotherapy treatments for recurrent disease, you won't be eligible. You also can't be taking certain other medications like biological response modifiers or steroids. If you have other uncontrolled serious health problems, a fish or shellfish allergy, or if you've taken omega-3 supplements in the last three months (or plan to during the study), you won't be able to participate.

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.

I am a man aged 18 to 100.
I have confirmed prostate cancer that is showing signs of returning (PSA increasing).
My cancer has not spread to other parts of my body.
I don't have a fish or shellfish allergy.
I haven't taken omega-3 supplements in the last 3 months and won't during the study.

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be given either the active omega-3 supplement (MAG-EPA) or a placebo (a dummy pill) to take every day for one year. You won't know which one you're taking. You'll have regular hospital visits for check-ups, blood tests (especially to monitor your PSA levels), and to make sure you're taking your medication as prescribed and that there are no unexpected side effects. The researchers will also ask you questions about your general health and how you're feeling. This study involves taking the supplement and attending appointments for a total of one year.

Potential risks and benefits

Participating in this study might offer the potential benefit of either slowing down your prostate cancer's progression or delaying the need for other treatments that have more side effects, even if you are taking the placebo it will help future science. However, as with any medication, there's always a small chance of side effects from the omega-3 supplement, although omega-3s are generally well-tolerated. It's also possible that the supplement might not work for you. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Centre de Recherche Clinique et Évaluative en Oncologie - Hôtel-Dieu de Québec
Verified postcode
Québec, Canada

Common questions

What is 'biochemical recurrence'?

This means your prostate cancer is showing signs of returning after treatment, usually by a rise in your PSA blood test.

What are omega-3 fatty acids?

These are healthy fats found in foods like oily fish. They are being studied for various health benefits.

What is a 'placebo'?

A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. It helps researchers compare effects.

Will I know if I'm taking the omega-3 supplement or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctor will know which you are taking until after the study is over.

How long will I be in the study?

You would be in the study, taking the supplement and attending appointments, for about one year.