MRI Screening for Prostate Cancer

Recruiting at 1 trial location

Overseen By Teresa Barry

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Metal fragments, Claustrophobia, No rectum, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether MRI scans (Prostate MRI) can detect serious prostate cancers early in men at higher risk. The study focuses on different groups: those with specific genetic mutations, a family history of prostate cancer, or a high genetic risk score. Men who have never had prostate cancer or prostate surgery and have no metal fragments or claustrophobia issues qualify as good candidates for this trial. As an unphased study, this trial allows participants to contribute to groundbreaking research that could enhance early detection methods for prostate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this MRI screening is safe for prostate cancer detection?

Research has shown that MRI scans safely help detect prostate cancer. Studies have found that both biparametric MRI (bpMRI) and multiparametric MRI (mpMRI) effectively identify significant prostate cancers. The bpMRI scan requires less time, potentially increasing patient comfort. No major safety differences exist between bpMRI and mpMRI, and neither has been linked to serious side effects. Thus, MRI screenings for prostate cancer are generally safe and should not pose significant risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRI screening for prostate cancer because it offers a non-invasive way to detect cancer early, especially in high-risk groups. Unlike traditional screening methods, like PSA tests or biopsies, MRI can provide detailed images of the prostate, potentially identifying aggressive cancers that might be missed otherwise. This technique could lead to earlier and more accurate diagnosis, reducing unnecessary treatments and focusing on significant disease. By tailoring screening strategies to genetic and familial risk factors, MRI can enhance personalized medicine approaches, offering a more targeted and efficient screening option.

What evidence suggests that Prostate MRI is effective for early detection of high-grade prostate cancer?

Research shows that MRI scans effectively detect prostate cancer. Studies have found that a simpler type of MRI, called biparametric MRI (bpMRI), performs as well as the more complex multiparametric MRI (mpMRI) in identifying serious prostate cancers. This means it can detect important cases without requiring more complicated tests. In fact, using MRI instead of traditional methods has saved lives and helped some men live longer. Additionally, a negative MRI result can help avoid unnecessary biopsies and diagnoses of less serious cancers. These findings suggest that MRI is a reliable and efficient screening option, especially for those at high risk. In this trial, participants will be grouped based on their risk factors, such as genetic mutations, family history, or genetic risk scores, to evaluate the effectiveness of MRI screening in different high-risk categories. ^{2 4 6 7 8}

Who Is on the Research Team?

Scott E. Eggener

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for men aged 18 and older who are at high risk of developing prostate cancer but have no known history of it. They should not have had any previous prostate surgery or a biopsy within the last three years, nor an MRI in that time frame. Men with metal fragments, severe claustrophobia, without a rectum, or those who've had hip replacement are excluded.

Inclusion Criteria

I have not had surgery or ablation for my prostate.

I have never been diagnosed with prostate cancer.

I am a man aged 18 or older.

Exclusion Criteria

Prostate biopsy done within last 3 years

I have had a hip replacement surgery.

Unable to tolerate MRI due to metal fragments or claustrophobia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Screening

Participants undergo MRI screening to identify high-grade prostate cancers

Every 3 years

1 visit (in-person) every 3 years

Follow-up

Participants are monitored for safety and effectiveness after MRI screening

15 years

What Are the Treatments Tested in This Trial?

Interventions

• Prostate MRI

Trial Overview

The study is testing if using Magnetic Resonance Imaging (MRI) can detect serious types of prostate cancer earlier and more reliably in men considered to be at high risk for this disease.

How Is the Trial Designed?

Group I: Low Risk (n=125): Experimental Treatment 1 Intervention

No known germline mutation, low genetic risk score (GRS \<1.5), and no known family history of prostate cancer.

Group II: High Risk- Positive Germline Mutation (n=40): Experimental Treatment 1 Intervention

Men who harbor known germline mutations that have been associated with an increased risk of prostate cancer and aggressive disease (e.g. BRCA2, ATM, PALB2, etc.) with or without a known family history of prostate cancer.

Group III: High Risk- High GRS (n=40): Experimental Treatment 1 Intervention

Men who harbor significantly increased disease risk based upon genetic risk score (GRS) value \>1.5 with or without a known family history of prostate cancer.

Group IV: High Risk- Family History (n=45): Experimental Treatment 1 Intervention

Men with a family history of prostate cancer in at least one sibling, father, uncle, or grandfather but no known increased genetic risk of prostate cancer (has no pathogenic or likely pathogenic mutation along with a low genetic risk score (GRS\<1.5).

Prostate MRI is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Prostate MRI for:

• Detection and localization of clinically significant prostate cancer
• Locoregional prostate cancer staging
• Detection of locoregional recurrence in a post-prostatectomy setting

Approved in United States as Prostate MRI for:

• Detection and localization of clinically significant prostate cancer
• Locoregional prostate cancer staging
• Detection of locoregional recurrence in a post-prostatectomy setting
• Assessment for active surveillance

Approved in Canada as Prostate MRI for:

• Detection and localization of clinically significant prostate cancer
• Locoregional prostate cancer staging
• Detection of locoregional recurrence in a post-prostatectomy setting

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

Multiparametric MRI (mp-MRI) significantly enhances the detection of clinically significant prostate cancer compared to traditional imaging methods, with MRI-ultrasound fusion biopsy showing up to a 20% increase in detection rates for men with no previous biopsies.

mp-MRI helps reduce over-detection of low-risk cancers and improves risk stratification for men with known low-risk disease, making it a valuable tool for guiding treatment decisions and minimizing unnecessary biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric MRI and targeted prostate biopsy: Improvements in cancer detection, localization, and risk assessment. Bjurlin, MA., Mendhiratta, N., Wysock, JS., et al.[2022]

In a study of 265 patients with suspected prostate cancer, 18.5% of those with normal or equivocal mp-MRI results were found to have cancer, with 9.8% diagnosed with clinically significant cancer (csCa), indicating that some patients may still require biopsy despite negative MRI findings.

The negative predictive value for normal MRI was 91.2%, suggesting that while many patients can safely avoid biopsy, careful consideration is needed, especially for those with equivocal results, as additional factors like PSA density and digital rectal exam findings can aid in decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a prostate biopsy be safely deferred on PI-RADS 1,2 or 3 lesions seen on pre-biopsy mp-MRI? Abdul Raheem, R., Razzaq, A., Beraud, V., et al.[2023]

In a study of 168 men with indeterminate mp-MRI results, 14% were found to have clinically significant prostate cancer, regardless of whether they chose immediate biopsy or a surveillance strategy.

The surveillance strategy, which involved monitoring PSA levels and conducting follow-up mp-MRI, allowed many men to avoid the risks and complications associated with immediate biopsy, while still identifying cancers with similar risk profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Radiologically Indeterminate Magnetic Resonance Imaging Signals in Men at Risk of Prostate Cancer. van der Sar, ECA., Kasivisvanathan, V., Brizmohun, M., et al.[2022]

Multiparametric magnetic resonance imaging (mp-MRI) shows moderate sensitivity (61%) and specificity (78%) for detecting disease progression in prostate cancer patients on active surveillance, based on a systematic review of 7 studies involving 800 patients.

Current evidence does not support replacing prostate biopsies with mp-MRI in active surveillance protocols, highlighting the need for institutions to evaluate their own mp-MRI diagnostic performance rather than relying solely on international guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the Use of Serial Multiparametric Magnetic Resonance Imaging During Active Surveillance of Prostate Cancer Avoid the Need for Prostate Biopsies?-A Systematic Diagnostic Test Accuracy Review. Hettiarachchi, D., Geraghty, R., Rice, P., et al.[2022]

Multiparametric magnetic resonance imaging (mp-MRI) demonstrated a high sensitivity of 90.4% for detecting index lesions in prostate cancer, including 93.3% sensitivity for clinically significant lesions, which are defined as having a volume greater than 0.5 mL or a Gleason score above 6.

While mp-MRI is effective for identifying significant prostate cancer, it struggles with detecting small-volume, low Gleason score cancers, indicating its potential use in risk stratification for better treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of prostate cancer index lesions with multiparametric magnetic resonance imaging (mp-MRI) using whole-mount histological sections as the reference standard. Russo, F., Regge, D., Armando, E., et al.[2018]

Multiparametric MRI (mpMRI) is currently the gold standard for visualizing prostate cancer, but it has several drawbacks that can affect its effectiveness.

Biparametric MRI (bpMRI) has been proposed as a potentially simpler and more efficient alternative to mpMRI, and recent studies are exploring its advantages in prostate cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short review of biparametric prostate MRI. Steinkohl, F., Pichler, R., Junker, D.[2020]

Biparametric MRI (bpMRI) has shown comparable diagnostic accuracy to multiparametric MRI (mpMRI) for detecting prostate cancer, offering advantages such as lower costs, reduced acquisition time, and fewer side effects due to the absence of contrast agents.

However, the effectiveness of bpMRI may be limited in general community settings, as most studies come from specialized centers, and there is a need for further research, including prospective multicenter studies, to validate its clinical application for early prostate cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future direction of imaging in prostate cancer: MRI with or without contrast injection. Pecoraro, M., Messina, E., Bicchetti, M., et al.[2022]

In a study involving 130 biopsy-naive patients suspected of prostate cancer, the use of multiparametric MRI (MP-MRI) combined with TRUS-fusion targeted biopsy did not significantly improve the detection rates of prostate cancer compared to routine TRUS-guided random biopsy.

Both methods showed similar overall cancer detection rates (64% for MP-MRI vs 57% for control) and rates of clinically significant cancer (55% for MP-MRI vs 45% for control), indicating that adding MP-MRI may not provide additional diagnostic benefits in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiopsy Multiparametric Magnetic Resonance Imaging for Prostate Cancer Diagnosis in Biopsy-naive Men with Suspected Prostate Cancer Based on Elevated Prostate-specific Antigen Values: Results from a Randomized Prospective Blinded Controlled Trial. Tonttila, PP., Lantto, J., Pääkkö, E., et al.[2022]

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