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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether or not Magnetic Resonance Images (MRI) will identify high-grade cancers earlier and more frequently in men at high risk of developing 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 data supports the effectiveness of the treatment Prostate MRI, Multiparametric MRI, Mp-MRI, Bi-Parametric MRI, Prostate Magnetic Resonance Imaging for prostate cancer?

Research shows that multiparametric MRI (mp-MRI) can improve the detection of significant prostate cancer, help in accurately locating cancer during biopsies, and enhance risk assessment, making it a valuable tool in diagnosing and managing prostate cancer. ^{1 2 3 4 5}

Is MRI screening for prostate cancer safe for humans?

The research does not specifically address safety concerns, but multiparametric MRI (mp-MRI) is described as a noninvasive imaging method, which generally suggests it is safe for human use. ^{1 3 5 6 7}

How is Prostate MRI different from other treatments for prostate cancer?

Prostate MRI, including multiparametric MRI (mpMRI) and biparametric MRI (bpMRI), is a noninvasive imaging technique that helps in accurately locating prostate cancer, improving risk assessment, and guiding targeted biopsies. Unlike other treatments, it does not involve surgery or medication, making it a less invasive option for diagnosing and managing prostate cancer. ^{1 2 3 5 8}

Research Team

Scott E. Eggener

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Multiparametric MRI and targeted prostate biopsy: Improvements in cancer detection, localization, and risk assessment. [2022]

2. Austria pubmed.ncbi.nlm.nih.gov

Short review of biparametric prostate MRI. [2020]

3. England 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. [2018]

4. Switzerland 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. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Management of Radiologically Indeterminate Magnetic Resonance Imaging Signals in Men at Risk of Prostate Cancer. [2022]

6. United States 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? [2023]

7. Netherlands 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The future direction of imaging in prostate cancer: MRI with or without contrast injection. [2022]