Active not recruitingPHASE3INTERVENTIONAL

PSMA PET/CT Guided Intensification of Therapy in Patients at Risk of Advanced Prostate Cancer

This study is exploring if a special scan called a PSMA PET/CT can improve how doctors treat men with prostate cancer. This scan is better at finding cancer cells than older methods. The study wants to see if using this scan to guide treatment, either radiotherapy or surgery, leads to better outcomes for patients. It will also check if this new approach causes more side effects, affects quality of life, or is good value for the NHS. Men taking part will either have the new scan to help plan their treatment, or they will receive standard care. This research aims to understand if more precise treatment based on the PSMA PET/CT scan can help stop the cancer from getting worse and improve men's lives. It's really about giving doctors better tools to fight prostate cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

800

Start

06 Jan 2021

Estimated completion

01 Jan 2029

Prostate Cancer

What is this study about?

This research is looking into a new way to treat prostate cancer, especially for men whose cancer is at a higher risk of spreading. It’s all about using an advanced scan, called a PSMA PET/CT, to get a much clearer picture of where the cancer is in the body. Traditional scans might miss some smaller areas of cancer, but the PSMA PET/CT is much more sensitive. Think of it like using a really powerful magnifying glass to see tiny details that would otherwise be invisible.

The main idea behind this study is that if doctors can see exactly where all the cancer cells are, they can then target them more effectively with treatments like radiotherapy (using strong X-rays to kill cancer cells) or surgery (removing the cancer). The study aims to find out if this more targeted approach, guided by the PSMA PET/CT scan, leads to better results for patients. In other words, will it help keep the cancer from coming back or spreading, and will it improve their health and well-being in the long run?

The study will also look at whether this new way of planning treatment has any unwanted effects or if it improves a patient's overall quality of life. Plus, it will check if using this special scan is a cost-effective choice for the NHS in the UK. Ultimately, the hope is that this research will provide strong evidence to show that PSMA PET/CT scans can significantly improve the care and outcomes for men with prostate cancer.

Key takeaways

This study aims to make prostate cancer treatment more precise.
It uses a new scan (PSMA PET/CT) to better locate cancer cells.
It compares new scan-guided treatment to standard care.
The goal is to improve cancer outcomes, quality of life, and cost-effectiveness.
Participants will receive either radiotherapy or surgery as their treatment.
You have the right to withdraw from the study at any time.

Who may be eligible?

This study is for men who have been diagnosed with prostate cancer and are planning to have treatment that aims to cure their cancer, either with radiotherapy or surgery. It's specifically for men whose cancer is considered to be at a higher risk of spreading.

You might be suitable if you've recently been diagnosed with higher-risk prostate cancer, or if you've already had surgery for prostate cancer and your PSA level (a marker for prostate cancer) has started to rise again, meaning you're now considering further radiotherapy. You need to be at least 18 years old and generally well enough to manage daily activities.

However, you wouldn't be able to join if you've recently had certain hormone treatments, if you've already had a PSMA PET/CT scan (unless it was for this study), or if you've received other types of local treatment for your prostate cancer besides surgery. Also, if your cancer has already clearly spread to other parts of your body based on standard scans, you wouldn't be eligible for this particular study.

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.

Have I been diagnosed with prostate cancer?
Am I planning to have surgery or radiotherapy to cure my cancer?
Is my prostate cancer considered to be at a higher risk of spreading?
Am I at least 18 years old and generally well?
Have I not recently had certain hormone treatments for prostate cancer?
Have I not already had this specific PSMA PET/CT scan before this study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first provide your agreement to join. The study will last for about 3 years. You'll be put into one of two groups by chance (like flipping a coin). One group will have the new PSMA PET/CT scan before their treatment. The other group will have their treatment planned using standard methods, without this specific scan.

Your treatment will then be given as planned by your doctors, either radiotherapy or surgery. The study involves regular check-ups and assessments to see how you are doing, how your cancer is responding, and if the treatment is affecting your quality of life. The research team will explain exactly what these visits involve and how long they will be. The goal is to carefully follow your progress over the study's duration.

Potential risks and benefits

Taking part in this study could potentially offer you the benefit of more precise and effective treatment for your prostate cancer, as the PSMA PET/CT scan might help doctors target the cancer better. This could lead to a better chance of successful treatment and potentially improved long-term health. As with any medical procedure or treatment, there are potential risks, but the study aims to use new methods while keeping side effects low. The research team will discuss all known and potential risks with you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (19)

BC Cancer Kelowna
Verified postcode
Kelowna, Canada
BC Cancer Vancouver
Verified postcode
Vancouver, Canada
Royal Victoria Regional Health Centre
Verified postcode
Barrie, Canada
St-Joseph's Healthcare
Verified postcode
Hamilton, Canada
Juravinski Cancer Centre
Verified postcode
Hamilton, Canada
Grand River Regional Cancer Centre
Verified postcode
Kitchener, Canada
London Health Sciences Centre
Verified postcode
London, Canada
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada
Hopital de la Cité de la Santé
Verified postcode
Laval, Canada
Charles Lemoyne Hospital
Verified postcode
Montreal, Canada
McGill University Health Center
Verified postcode
Montreal, Canada
CHU de Québec
Verified postcode
Québec, Canada

Common questions

What is a PSMA PET/CT scan?

It's a special type of scan that uses a tiny amount of a radioactive substance to highlight prostate cancer cells, making them clearer for doctors to see than with standard scans.

Will I definitely get the new scan if I join?

Not necessarily. Participants are randomly assigned to either receive the new scan to guide their treatment or to receive standard care, which doesn't include this specific scan.

How long will I be in the study?

The study collects information over a period of 3 years, though your direct involvement might be focused around your treatment and follow-up during that time.

What kind of treatment will I get?

You will receive either radiotherapy or surgery, decided by your doctors, which aims to cure your prostate cancer. The study is about how this treatment is planned.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your medical care.