250 Participants Needed

MRI Screening for Prostate Cancer

Recruiting at 1 trial location
SE
MO
TB
Overseen ByTeresa Barry
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.24678

Who Is on the Research Team?

Scott Eggener, MD - UChicago Medicine

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
See 2 more

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?
4Treatment groups
Experimental Treatment
Group I: Low Risk (n=125):Experimental Treatment1 Intervention
Group II: High Risk- Positive Germline Mutation (n=40):Experimental Treatment1 Intervention
Group III: High Risk- High GRS (n=40):Experimental Treatment1 Intervention
Group IV: High Risk- Family History (n=45):Experimental Treatment1 Intervention

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

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Approved in European Union as Prostate MRI for:
🇺🇸
Approved in United States as Prostate MRI for:
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Approved in Canada as Prostate MRI for:

Find a Clinic Near You

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.
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.
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.
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]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38830219/
Lifetime Health and Economic Outcomes of Biparametric ...Results of base-case analysis: For 1000 men, first-line bpMRI versus first-line PSA testing prevented 2 to 3 PCa deaths and added 10 to 30 life- ...
Evaluating Biparametric Versus Multiparametric Magnetic ...Our results demonstrate that biparametric MRI (bpMRI) is noninferior to multiparametric MRI (mpMRI) in diagnosing clinically significant prostate cancer, as ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39321360/
Results after Four Years of Screening for Prostate Cancer ...In this trial, omitting biopsy in patients with negative MRI results eliminated more than half of diagnoses of clinically insignificant prostate cancer.
Millions could benefit from faster biparametric MRI scan for ...The PRIME trial confirms that a biparametric MRI scan is just as effective at diagnosing prostate cancer as a multiparametric MRI.
Biparametric Versus mpMRI for Prostate Cancer DetectionThe study concludes that bpMRI is a viable, cost-effective alternative for primary prostate cancer diagnosis, offering broader access without compromising ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40928788/
Biparametric vs Multiparametric MRI for Prostate Cancer ...Biparametric MRI detected clinically insignificant cancer in 45 of 490 men (9.2%), compared with 47 of 490 men (9.6%) with the use of ...
Trial Proves Biparametric MRI Is Accurate for Prostate ...Using biparametric MRI can reduce MRI scan time from approximately 40 minutes to 20 minutes, leading to more efficient scan use, less toxicity ...
Diagnostic accuracy of abbreviated biparametric MRI for ...Clinical relevance Prostate MRI may improve cancer detection independently of PSA testing, with abbreviated protocols enhancing feasibility and ...
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