Active not recruitingPHASE2INTERVENTIONAL

Multi-modality Imaging (PCa) Using Sodium MRI and PSMA PET in Men Pre-prostatectomy

This study aims to discover the best imaging techniques for detecting and understanding prostate cancer before surgery. For men already scheduled for prostate removal, we are using advanced scans like Sodium MRI, PSMA PET, and Multiparametric MRI. We want to see how well these scans can show where the cancer is and how aggressive it might be. By comparing the scan results with what we find after surgery, we hope to improve how we identify and treat prostate cancer. This could lead to better decisions for patients and potentially reduce the need for aggressive treatments when they are not necessary, ultimately improving their quality of life.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Glenn Bauman

Enrolment target

Start

04 Feb 2021

Estimated completion

01 Sep 2025

Prostate Cancer Prostate Adenocarcinoma Prostate Neoplasm

What is this study about?

This study is investigating new and better ways to look at prostate cancer using special body scans. For men who are already going to have surgery to remove their prostate, we are adding extra scans before their operation. These extra scans include something called Sodium MRI, another called PSMA PET, and a standard Multiparametric MRI.

The main goal is to find out which of these scans, or a combination of them, does the best job at showing exactly where the cancer is inside the prostate and how aggressive it might be. Aggressiveness is like understanding how quickly the cancer might grow or spread. By knowing this better before surgery, doctors can make more informed decisions about the best way to treat each man's cancer. This could mean avoiding unnecessary treatments if the cancer is not very aggressive, or making sure the right treatment is given if it is.

We believe that by improving these scanning methods, we can help men with prostate cancer have a better quality of life. The study works by comparing what the scans show before surgery with what doctors find when they examine the prostate tissue after it has been removed. This comparison helps us learn which scanning techniques are most helpful. Ultimately, we hope to make these advanced scans more widely available and easier to use, especially for keeping an eye on less aggressive cancers.

Key takeaways

This study uses advanced scans to better understand prostate cancer.
It aims to improve how doctors find and assess prostate cancer before surgery.
The goal is to help make better treatment decisions and improve patient quality of life.
You would receive extra imaging scans before your planned prostate removal surgery.
The study compares scan results with actual cancer tissue after surgery to find the most helpful methods.

Who may be eligible?

Participating in this study means you are a man, 18 years or older, who has recently been diagnosed with prostate cancer through a biopsy. You must also be planning to have surgery to remove your prostate as part of your standard care, and you need to be able to give your informed consent to join the study.

There are certain reasons why you might not be able to join. For example, if you've already had treatment for your prostate cancer, such as hormone therapy, or if you've taken certain medications like finasteride or dutasteride in the last six months (unless you've had a break from them). Also, if your prostate is very large, or if you have severe kidney problems or certain metal implants that make MRI scans unsafe, you wouldn't be able to participate. We also need to make sure you won't have a strong reaction to the dyes sometimes used in scans.

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 a recent prostate cancer diagnosis confirmed by biopsy?
Are you scheduled for surgery to remove your prostate?
Have you not had any prostate cancer treatment before?
Are you able to have MRI scans (no pacemaker, certain metals, or severe kidney problems)?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will have a series of extra imaging scans before your planned prostatectomy surgery. These will include a Sodium MRI, a PSMA PET scan (which involves a special injection), and a Multiparametric MRI. These scans are done as part of the study but before your standard surgery. The total duration of your involvement in the study will mostly revolve around these pre-surgery scans and then allowing us to compare the scan results with the tissue from your surgery, which happens as part of your normal treatment. There are no additional medications specifically for the study. You will give your consent to participate before any study-related procedures begin.

Potential risks and benefits

Participating in this study could offer several potential benefits, including receiving very detailed information about your prostate cancer from advanced imaging techniques. This information may help researchers learn how to best use these scans to guide future treatment decisions for men with prostate cancer. Potential risks involve those associated with the imaging scans themselves, such as exposure to small amounts of radiation from the PET scan, and potential allergic reactions to contrast dyes used in some scans. There are also the general risks associated with MRI scans, such as discomfort in the scanner for some individuals. You are free to withdraw from the study at any time without affecting your standard medical care.

Locations (1)

London Health Sciences Centre
Verified postcode
London, Canada

Common questions

What exactly is a Sodium MRI?

A Sodium MRI is a special type of MRI scan that looks at sodium levels in your body. In prostate cancer, high sodium levels can sometimes mean the cancer is more active.

What is a PSMA PET scan?

A PSMA PET scan uses a very tiny amount of a radioactive substance that sticks to prostate cancer cells. This helps doctors see where the cancer is and how much of it there might be.

Will these scans replace my surgery?

No, these scans will not replace your surgery. You are still having your prostate removed as planned. These scans are extra steps to help researchers learn more for future patients.

Will I get my scan results immediately?

The results of these research scans will be used for the study and compared with your pathology after surgery. Your doctors will discuss your regular surgical and pathology results with you as part of your standard care.

Is there any cost to me for these extra scans?

No, if you take part in the study, there will be no additional costs to you for the study-specific scans and procedures.