RecruitingOBSERVATIONAL

ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer

This study, called ART-Pro, is testing new ways to find prostate cancer using advanced MRI scans. Currently, a common scan called multiparametric MRI (mpMRI) is used, but it needs an injection and an expert to read it well. This study is exploring if a combination of two newer techniques, biparametric MRI (bpMRI) and Restriction Spectrum Imaging (RSIrs), can achieve similar or better results. The goal is to make it easier to spot important prostate cancers, meaning doctors with less specialist experience might be able to read the scans effectively and patients wouldn't need an injection. We're looking for 500 men across 5 hospitals to take part and help improve how we detect prostate cancer.

At a glance

Status

Recruiting

Sponsor

University of California, San Diego

Enrolment target

500

Start

15 Dec 2023

Estimated completion

01 Jul 2029

Prostate Cancer

What is this study about?

This study, called ART-Pro, is all about improving how doctors find prostate cancer. Currently, a special type of scan called 'multiparametric MRI' (mpMRI) is often used. While it's good, it has a couple of downsides: it usually needs an injection of a special dye, and it takes a very experienced radiologist (a doctor who reads scans) to interpret the results accurately.

The researchers in this study are excited about two newer MRI techniques: 'biparametric MRI' (bpMRI) and 'Restriction Spectrum Imaging restriction score' (RSIrs). They believe that by combining these two, they might be able to create a method that works just as well, if not better, than the current mpMRI, but without the need for an injection. Crucially, they hope this new combined method will also make it easier for radiologists with varying levels of experience to accurately spot important prostate cancers, meaning more doctors could use it effectively.

This study is important because finding prostate cancer accurately and at an early stage can lead to better treatment outcomes. By making the scanning process simpler and the results easier to interpret for a wider range of radiologists, this research could ultimately help more men get the right diagnosis and treatment for prostate cancer. It could also mean fewer men need the contrast injection during their MRI, which is often preferred by patients.

Key takeaways

New MRI methods are being tested to find prostate cancer better.
The study aims to avoid injections during prostate MRI scans.
It hopes to make MRI results easier for all doctors to understand.
500 men from different hospitals will help with this research.
The results could improve prostate cancer detection for many future patients.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been sent for an MRI scan of your prostate because your doctor suspects you might have prostate cancer. Your MRI scan will need to follow a specific set of instructions designed for this study.

There are some reasons why you wouldn't be able to join. For example, if you've already been diagnosed with prostate cancer in the past, or if you've had surgery on your prostate. You also can't take part if you have other types of cancer near your prostate at the moment.

Certain metal implants in your body, like a hip replacement or other medical devices, might prevent you from having an MRI or following the study's specific scan setup, so these would also mean you couldn't join. The study also cannot include individuals who are currently in prison.

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 18 years old or older?
Have you been referred for a prostate MRI because cancer is suspected?
Have you *never* had prostate cancer diagnosed before?
Do you have any metal implants (like a hip replacement) or devices in your body?
Are you able to lie still for an MRI scan with a specific setup?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have an MRI scan of your prostate. This scan will use the advanced techniques being tested. The study will then collect information from your medical records over time, such as the results of any biopsies you have or details from any surgery if you have one. You won't have any extra visits just for the study beyond your usual medical appointments. The total duration of your participation will involve the initial MRI scan and then allow researchers to follow your health outcomes as part of your standard care.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information doctors learn could help improve how prostate cancer is detected for future patients. There are very few risks associated with an MRI scan itself, as it doesn't use radiation, and this study aims to use scans without an injection. However, having an MRI means lying still in a scanner, which some people find uncomfortable. Remember, you can choose to leave the study at any time without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of California San Diego
Verified postcode
San Diego, United States· Recruiting
University of California, San Francisco
Verified postcode
San Francisco, United States· Not yet recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Not yet recruiting
Weill Cornell Medical College
Verified postcode
New York, United States· Not yet recruiting
Cambridge University Hospitals NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom· Not yet recruiting

Common questions

What is the main goal of this study?

The main goal is to see if new MRI scanning methods can find important prostate cancers more effectively and easily than current methods, without needing an injection.

Will I get an injection for my MRI in this study?

The study is specifically looking at MRI techniques that do *not* require an injection of contrast dye, aiming to avoid this for patients.

Who is interpreting the scans in this study?

Initially, expert doctors will read scans using different methods. Later, doctors with different levels of experience will also read scans to see how well the new methods work for everyone.

Will this study change my prostate cancer treatment?

This study focuses on improving how prostate cancer is *detected*. Any treatment decisions will still be made by your doctor based on all your test results and medical situation.

How long will I be involved in this study?

Your main involvement is the MRI scan. After that, the researchers will follow your medical outcomes (like biopsy results) using your existing health records.

How to find out more

Tyler Seibert, MD, PhD

tseibert@health.ucsd.edu 858-246-2180 Official trial record

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