Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Management of Castration-Resistant Prostate Cancer with Oligometastases

This research trial is for men with advanced prostate cancer who have already had hormone treatment, but their cancer has started to grow again and spread to a few new spots (called oligometastases). We want to see if adding a special type of focused radiation, called SBRT, to their usual hormone therapy can help. The standard treatment involves hormone therapy with medicines like Enzalutamide. The study compares giving this standard treatment alone versus giving it with SBRT to the cancer spots. The main aim is to find out if SBRT can delay the cancer from spreading further and put off the need for different kinds of treatments, ultimately improving patients' quality of life and survival.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Enrolment target

102

Start

01 Oct 2016

Estimated completion

01 Aug 2041

Castration-resistant Prostate Cancer Patients with Oligometastases

What is this study about?

Prostate cancer is the most common cancer affecting men. When prostate cancer spreads to other parts of the body, it's called metastatic prostate cancer. Often, men receive hormone therapy to help control the cancer, but over time, the cancer can become resistant to this treatment and start growing again, even with ongoing hormone therapy. This is called 'castration-resistant prostate cancer' (CRPC).

Recently, newer hormone therapies like Enzalutamide have become available for CRPC. This study explores an exciting new idea: what if we could target these new cancer spots, called 'oligometastases' (meaning a limited number of new cancer sites), with a special type of very focused radiation treatment called Stereotactic Body Radiotherapy (SBRT)? The thinking behind this is that by zapping these specific spots, we might be able to keep the cancer from spreading further and delay the need for more intensive treatments.

So, this trial is comparing two approaches for men with CRPC who have a limited number of new cancer spots. One group will receive the current standard care, which is continuing their current hormone treatment along with a new-generation hormone therapy like Enzalutamide. The other group will receive this exact same standard treatment, but with the addition of SBRT directly to their new cancer spots. We want to understand if adding SBRT can really make a difference by slowing down the cancer's growth and giving patients more time before they need other therapies.

Key takeaways

This study investigates a new approach for prostate cancer that has resisted hormone therapy and spread to a few spots.
It aims to see if focused radiation (SBRT) can delay cancer progression when added to standard hormone treatment.
Participation involves random assignment to either standard hormone therapy or standard therapy plus SBRT.
Regular checks, including scans and blood tests, will monitor your health and cancer status.
The study hopes to find ways to extend the time before more treatments are needed and improve quality of life.
You can withdraw from the study at any time without affecting your future medical care.

Who may be eligible?

To be able to join this study, you need to be a man aged 18 or older with prostate cancer that has been confirmed by a biopsy. You must be currently receiving hormone therapy (either with medication or surgery to remove the testicles) and your testosterone levels need to be low. Your cancer must have started to grow again despite hormone therapy, and you need to have a limited number of new cancer spots, which can be treated with SBRT. These spots should not have been previously treated with radiation.

We're looking for men who haven't had chemotherapy for their prostate cancer before. You'll also need to meet certain health criteria, which the study doctors will check, and be well enough to take part in the study activities.

There are also some reasons why you might not be able to join. For example, if you have too many cancer spots, if the cancer has spread to your brain or liver, or if any of your cancer spots have already been treated with radiation, you wouldn't be eligible. Your study doctor will review all the detailed rules with you to see if this trial is a good fit.

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 aged 18 or older?
Do you have prostate cancer confirmed by biopsy?
Are you currently receiving hormone therapy (or have had surgical removal of testicles)?
Has your prostate cancer started growing again despite hormone therapy?
Do you have a small, limited number of new cancer spots that can be treated with radiation?
Have you NOT had chemotherapy for your prostate cancer before?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will first have some checks, including detailed scans to confirm where the cancer is and blood tests. You will then be randomly assigned, like flipping a coin, to one of two groups: either you'll receive the standard hormone therapy (your usual hormone treatment plus a new hormone drug like Enzalutamide) or you'll receive the standard hormone therapy AND a special type of radiation (SBRT) to your cancer spots.

Throughout the study, you'll have regular follow-up appointments. These will include blood tests, especially to check your PSA levels, which will be done every 6 to 12 weeks. You’ll also have repeat scans at specific times (after 6, 9, 12, 18, and 24 months) or if your PSA levels suggest the cancer might be growing again. The total length of your participation will depend on how your cancer responds to treatment.

Potential risks and benefits

Taking part in this study could potentially offer you a new treatment option (SBRT) that might help control your cancer for longer. However, like all medical treatments, there are potential risks. SBRT, while highly focused, can cause side effects depending on the area being treated. These will be fully explained by the study team. The standard hormone therapy also has known side effects, which your doctor will discuss with you. You should also know that there’s no guarantee that participating will benefit you personally, as it's a research study. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (11)

BC CANCER Vancouver
Verified postcode
Vancouver, Canada
CancerCare Manitoba
Verified postcode
Winnipeg, Canada
Nova Scotia Cancer Centre
Verified postcode
Halifax, Canada
Juravinski Cancer Centre
Verified postcode
Hamilton, Canada
London Regional Cancer Program - London Health Sciences Centre
Verified postcode
London, Canada
Hopital Charles-Lemoyne
Verified postcode
Longueuil, Canada
Centre Hospitalier de l'Université de Montréal (CHUM) - Hopital Notre Dame
Verified postcode
Montreal, Canada
Jewish General Hospital, McGill University
Verified postcode
Montreal, Canada
McGill University Health Center
Verified postcode
Montreal, Canada
CHU de Quebec-Universite Laval
Verified postcode
Québec, Canada
Centre Hospitalier régional de Trois-Rivières
Verified postcode
Trois-Rivières, Canada

Common questions

What does 'Castration-Resistant Prostate Cancer' mean?

It means your prostate cancer is still growing, even though you've been on hormone therapy to lower your testosterone levels.

What are 'Oligometastases'?

These are a small, limited number of cancer spots that have spread from the original prostate cancer to other parts of your body.

What is SBRT?

SBRT stands for Stereotactic Body Radiotherapy. It's a very precise type of radiation that delivers high doses to specific cancer spots, aiming to destroy them.

Will I definitely get the new SBRT treatment?

You will be randomly assigned to either receive the standard hormone therapy alone or the standard therapy plus SBRT. You won't be able to choose which group you're in.

What are LHRH agonists and Enzalutamide?

LHRH agonists are medications that lower testosterone. Enzalutamide is a newer hormone therapy that further blocks the effects of hormones on prostate cancer cells.