Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)
This study is for men with prostate cancer that has come back in a small number of places after their initial treatment. It's called "recurrence-directed therapy" (RDT), which means doctors target these specific cancer spots with radiation or surgery. We want to find out if adding a hormone-blocking drug, ELIGARD®, to this targeted treatment works better than RDT alone to keep the cancer from growing. This drug aims to lower male hormones which can fuel prostate cancer. Participants will either receive RDT by itself or RDT plus ELIGARD® for a year. We'll monitor their health and the cancer's progress for 36 months to see which approach is more effective.
At a glance
What is this study about?
This study is for men who have had a type of prostate cancer called adenocarcinoma, which has been previously treated with radiation but has unfortunately started to come back. Crucially, the cancer has only reappeared in a few, limited spots – doctors call this "oligo-metastatic." These spots are still sensitive to hormone therapy, meaning lowering male hormones can help control the cancer.
We are investigating a treatment approach where doctors directly target these recurrent cancer sites with either more radiation or surgery. This is what we call "Recurrence-Directed Therapy" (RDT). The main question of this study is whether adding a hormone-blocking medicine called ELIGARD® to this targeted treatment makes it more effective. ELIGARD® works by reducing the amount of male hormones in the body, which can help slow down the growth of prostate cancer cells.
The idea is to see if combination therapy (RDT plus ELIGARD®) can keep the cancer from growing or spreading for a longer time compared to using RDT alone. We also want to understand how these treatments affect your overall health and quality of life. By comparing these two approaches, we hope to find a better way to manage prostate cancer that has returned in a limited way.
Key takeaways
- This study compares targeted treatment (RDT) alone vs. RDT plus a hormone drug (ELIGARD®) for prostate cancer that has returned in a few spots.
- The goal is to see if adding ELIGARD® helps keep the cancer from growing for longer.
- Participants will have regular check-ups for 36 months.
- ELIGARD® is taken for 12 months if assigned to that group.
- This study is for men whose prostate cancer came back in a limited way after initial radiation treatment.
Who may be eligible?
This study is looking for men at least 18 years old who have been diagnosed with prostate adenocarcinoma that returned after being treated with radiation therapy at least two years ago. The cancer must have only returned in five or fewer spots, and these spots must be suitable for treatment with radiation or surgery.
You cannot join if you've already had hormone therapy in the last two years, or other specific cancer treatments like chemotherapy for prostate cancer. Your general health should be good enough to participate, and your PSA level needs to be within a certain range.
There are also specific medical conditions or previous treatments that would prevent you from taking part, such as certain types of cancer spreading to the brain or spine, or if you've had a severe allergic reaction to ELIGARD® or similar medications before.
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?
- Has your prostate cancer come back in 5 or fewer spots after previous radiation treatment?
- Have you not received hormone therapy in the last two years?
- Are the returned cancer spots suitable for treatment with radiation or surgery?
- Is your general health good enough to take part in medical treatment?
What does participation involve?
If you join this study, you will be assigned by chance to one of two groups: either receiving targeted radiation or surgery (RDT) alone, or RDT alongside the hormone-blocking drug ELIGARD® for 12 months. This is a "multi-centre, open-label" study, meaning that both you and your doctors will know which treatment you are receiving, and it's being conducted in several different hospitals.
Throughout the study, you will have regular check-ups at the hospital every three months. During these visits, doctors will monitor how the cancer is responding, check for any new side effects, and assess your general health. You will also be asked to fill out questionnaires about your quality of life. The total follow-up period for all participants is 36 months from when you start the study.
Potential risks and benefits
Locations (3)
- Juravinski Cancer CentreVerified postcodeHamilton, Canada· Recruiting
- The Ottawa Hospital Regional Cancer CentreVerified postcodeOttawa, Canada· Not yet recruiting
- Jewish General HospitalVerified postcodeMontreal, Canada· Recruiting
Common questions
What does 'oligo-metastatic' mean?
It means your cancer has spread to a limited number of spots, typically five or fewer, in other parts of your body.
What is ELIGARD®?
ELIGARD® is a hormone-blocking drug that lowers the amount of male hormones in your body, which can help slow down prostate cancer growth.
How long will I take ELIGARD® if I'm in that group?
If you're in the group receiving ELIGARD®, you will take it for 12 months.
What is 'recurrence-directed therapy' (RDT)?
RDT means doctors specifically target the cancer spots that have come back with either radiation or surgery, rather than treating the whole body.
How often will I have hospital visits during the study?
You will have standard clinic visits every three months.
How to find out more
Lisa Rudd-Scott, RN BScN
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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