500 Participants Needed

RSI MRI for Prostate Cancer

(ART-Pro Trial)

Recruiting at 4 trial locations
TS
Overseen ByTyler Seibert, MD, PhD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new MRI techniques to better detect significant prostate cancer without the usual drawbacks. Typically, detecting prostate cancer with MRI requires a special dye and an expert radiologist. The trial aims to use two new MRI methods that could enable regular radiologists to find cancer just as effectively. It seeks men already scheduled for a prostate MRI due to cancer suspicion and who meet specific criteria, such as not having any metal implants.

As an unphased study, this trial provides a unique opportunity to contribute to advancements in prostate cancer detection technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these advanced MRI techniques are safe for detecting prostate cancer?

This trial explores new MRI methods to detect prostate cancer. While specific safety data for these new MRI techniques is not yet available, MRI (Magnetic Resonance Imaging) is a common and trusted imaging method. It is generally safe because it doesn't use harmful radiation like X-rays.

The trial employs two methods: biparametric MRI (bpMRI) and Restriction Spectrum Imaging (RSI). These aim to detect cancer more effectively without some drawbacks of current methods, such as the need for IV contrast, which can sometimes cause allergic reactions. Notably, bpMRI doesn't require IV contrast.

Since these are variations of existing MRI techniques, and given MRI's history of safety, these methods are expected to be well-tolerated. However, like any medical procedure, some risks or discomforts may occur. Discuss any concerns with the trial team or your doctor.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of biparametric MRI and advanced, quantitative diffusion MRI to enhance prostate cancer detection. Unlike traditional methods like PSA tests or standard MRI scans, these advanced imaging techniques aim to provide more precise and detailed views of prostate tissue. This could lead to earlier and more accurate diagnosis, potentially improving treatment outcomes and reducing unnecessary biopsies. By using advanced imaging, the hope is to make prostate cancer detection less invasive and more reliable.

What evidence suggests that these MRI techniques are effective for detecting clinically significant prostate cancer?

Research has shown that biparametric MRI (bpMRI) and the Restriction Spectrum Imaging restriction score (RSIrs) can detect significant prostate cancer without requiring IV contrast dye. Studies have found that these advanced MRI methods enable non-specialist radiologists to achieve accuracy comparable to expert radiologists. This accuracy is crucial for identifying prostate cancer that requires treatment. By eliminating the need for IV contrast, these methods could make screening safer and more comfortable for patients. Early evidence suggests that RSIrs alone might effectively identify significant prostate cancer. Overall, these techniques aim to enhance cancer detection while reducing the need for expert interpretation and contrast dyes.678910

Who Is on the Research Team?

TS

Tyler Seibert, MD, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

Inclusion Criteria

I am referred for a prostate MRI due to suspected cancer.
My MRI was done following the ART-Pro protocol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

ART-Pro-1

Prospective evaluation of bpMRI, mpMRI, and RSIrs techniques by expert radiologists

ART-Pro-2

Retrospective evaluation of MRI techniques by radiologists of varying experience levels

Follow-up

Participants are monitored for medical outcomes such as biopsy results or surgery pathology

What Are the Treatments Tested in This Trial?

Interventions

  • RSI MRI

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ART-Pro-1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

GE Healthcare

Industry Sponsor

Trials
307
Recruited
634,000+
Fotis Vlachos profile image

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

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Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Cambridge University Hospitals NHS Foundation Trust

Collaborator

Trials
280
Recruited
501,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Weill Medical College of Cornell University

Collaborator

Trials
1,103
Recruited
1,157,000+

Citations

ART-Pro: Clinical Trial Evaluating Biparametric MRI and ...

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

Trial Protocol Advanced Restriction Imaging and ...

ART-Pro-1 will evaluate bpMRI, mpMRI, and RSIrs on the accuracy of expert radiologists' detection of csPCa and will evaluate RSIrs as a stand-alone, ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39811103/

Advanced Restriction Imaging and Reconstruction ...

ART-Pro is a multisite, multinational trial that aims to evaluate whether IV contrast can be avoided in the setting of standardized, state-of-the-art image ...

ART-Pro: Clinical Trial Evaluating Biparametric MRI and ...

This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate ...

ART-Pro: Clinical Trial Evaluating Biparametric MRI and ...

This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate cancer (csPCa).

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