All studies
Enrolling by invitationPHASE2, PHASE3INTERVENTIONAL

Prostate Cancer Patient Management With 18F-DCFPyL PET/CT

This study is investigating a special type of scan called 18F-DCFPyL PET/CT for men with prostate cancer. The main goal is to see if having this advanced scan helps doctors decide on the best treatment plan compared to current methods. We want to understand if the information from this new scan changes the treatment approach. This study is for men either newly diagnosed with high-risk prostate cancer, or for those whose prostate cancer has returned after treatment. Participants will have the scan and then experts will review the results, alongside other medical information, to see if the scan influences the ideal management plan. We also want to monitor for any immediate side effects from the scan.

At a glance

Status
Enrolling by invitation
Phase
PHASE2, PHASE3
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Enrolment target
1,500
Start
22 Jun 2018
Estimated completion
01 Jun 2028

What is this study about?

This study is all about improving how doctors manage prostate cancer in men. Prostate cancer is a common cancer that affects men, and finding the best way to treat it is really important. This research is focusing on a special type of scan called an 18F-DCFPyL PET/CT. You might have heard of other scans like CT scans or MRI scans; a PET/CT scan combines two types of images to give doctors a very detailed picture of what's happening inside the body.

The main idea behind this study is to see if this particular 18F-DCFPyL PET/CT scan helps doctors make better decisions about your treatment plan. Currently, doctors use various tests and scans to decide on the best way to treat prostate cancer. This study wants to find out if adding this new scan changes or improves those treatment decisions. Experts will look at your information both *before* and *after* you have this scan to see if their ideas for your best care plan change.

This study will involve men who have already been diagnosed with prostate cancer. This includes men with a higher-risk type of prostate cancer that hasn't been treated yet, and also men whose prostate cancer has come back after previous treatment. The hope is that through this research, we can learn whether this advanced scan can provide valuable information that leads to more effective and personalised treatment choices for men with prostate cancer.

Key takeaways

  • The study explores a new advanced scan for prostate cancer.
  • It aims to see if this scan improves treatment planning.
  • It's for men with high-risk prostate cancer or if it has returned.
  • Participation involves one special scan and an injection.
  • No extra treatments or ongoing visits are required for the study itself.
  • You can withdraw from the study at any time.

Who may be eligible?

This study is looking for men who have been diagnosed with prostate cancer. You must be 18 years old or older. You should be generally well enough to take part in the study, which means you can handle activities of daily living and are not too unwell or unstable.

There are two main groups of men this study is looking for:

* **Group A:** Men newly diagnosed with prostate cancer that is considered 'high risk'. This might mean your cancer is more aggressive (based on something called a Gleason score), your PSA blood test level is quite high, or the cancer seems to have spread a bit, or if other scans haven't given clear answers. * **Group B:** Men whose prostate cancer has come back after they've had treatment for it. This is usually noticed by a rise in a blood test called PSA.

You would not be able to join if you are too unwell, too heavy for the scanner bed, or if you have severe claustrophobia that would prevent you from having the scan. You also need to be able to lie flat for up to 40 minutes and have a small tube placed in your arm for the injection.

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.

  1. Are you a man, aged 18 or over?
  2. Have you been diagnosed with prostate cancer?
  3. Are you generally well enough to have a scan?
  4. Do you have high-risk prostate cancer (untreated) OR has your prostate cancer returned after treatment (shown by a rising PSA)?
  5. Can you lie still for about 40 minutes and have a small injection?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll continue to receive your usual care from your doctor for your prostate cancer. The only extra part of this study will be having the 18F-DCFPyL PET/CT scan. Before the scan, you'll have a small injection of the special tracer liquid (18F-DCFPyL) into a vein, usually in your arm. This liquid helps the scanner see the cancer better. After the injection, you'll have the PET/CT scan, which involves lying still on a bed that moves through a doughnut-shaped machine. This scan usually takes up to 40 minutes.

There are no additional regular visits or follow-up appointments specifically for this study beyond your standard medical care. The study aims to gather information from this one scan and your existing medical records to see how the scan might change treatment decisions. We will also monitor you for a short time after the injection, usually up to 90 minutes, to check for any immediate side effects.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, though they are not guaranteed. The advanced scan might provide your doctors with more detailed information about your cancer, which could help them make a more informed decision about your treatment. However, since this is a research study, we don't yet know if this scan will definitely change your treatment or improve your outcome compared to existing tests. Potential risks include discomfort from the injection and lying still for the scan. There is also a very small amount of radiation from the scan, similar to other medical imaging tests. Immediate side effects from the injected medicine will be monitored for about 90 minutes. Remember, participating in any research study is entirely voluntary, and you are free to withdraw at any time without giving a reason, and this will not affect your routine medical care.

Locations (1)

  • Jewish General Hospital
    Verified postcode
    Montreal, Canada

Common questions

What is 18F-DCFPyL PET/CT?

It's a special type of scan that combines two imaging techniques (PET and CT) after you've been given a small amount of a special tracer liquid. It helps doctors get detailed pictures inside your body to see prostate cancer.

Will this scan change my current treatment?

The study aims to see if the scan *could* change treatment decisions. However, the study itself doesn't make treatment recommendations; your doctors will still decide your care based on all your information.

Is the injection safe?

The injection contains a very small, safe amount of a tracer that helps the scan work. You will be monitored for up to 90 minutes after the injection for any immediate side effects.

How long does the scan take?

After the injection, the actual scan involves lying still for up to 40 minutes.

Do I have to do anything else for the study?

No, beyond the scan itself and your regular medical care, there are no extra appointments or medications required for this study.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Prostate Cancer Patient Management With 18F-DCFPyL PET/CT…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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