MRI Screening for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Chicago
Disqualifiers: Metal fragments, Claustrophobia, No rectum, others
No Placebo Group
Approved in 3 Jurisdictions
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.
12345Is 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.
13567How 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.
12358Eligibility 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
+2 more
Trial 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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Group I: Low Risk (n=125):Experimental Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NorthShore University Health System - Glenbrook HospitalGlenview, IL
University of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
Multiparametric MRI and targeted prostate biopsy: Improvements in cancer detection, localization, and risk assessment. [2022]Multiparametric-MRI (mp-MRI) is an evolving noninvasive imaging modality that increases the accurate localization of prostate cancer at the time of MRI targeted biopsy, thereby enhancing clinical risk assessment, and improving the ability to appropriately counsel patients regarding therapy.
Short review of biparametric prostate MRI. [2020]Magnetic resonance imaging (MRI) of the prostate has become the gold standard for visualization of prostate cancer. Prostate MRI is usually performed as multiparametric MRI (mpMRI). Since mpMRI has several drawbacks, a biparametric MRI (bpMRI) of the prostate has been proposed. Many studies have been published on mpMRI and bpMRI in recent years. This short review offers an overview of the latest developments in this rapidly evolving field of research.
Detection of prostate cancer index lesions with multiparametric magnetic resonance imaging (mp-MRI) using whole-mount histological sections as the reference standard. [2018]To evaluate the sensitivity of multiparametric magnetic resonance imaging (mp-MRI) for detecting prostate cancer foci, including the largest (index) lesions.
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]Multiparametric magnetic resonance imaging (MP-MRI) may improve the detection of clinically significant prostate cancer (PCa).
Management of Radiologically Indeterminate Magnetic Resonance Imaging Signals in Men at Risk of Prostate Cancer. [2022]Multiparametric magnetic resonance imaging (mp-MRI) is becoming an increasingly important diagnostic tool for prostate cancer. So far there has been little focus on management for indeterminate mp-MRI results.
Can a prostate biopsy be safely deferred on PI-RADS 1,2 or 3 lesions seen on pre-biopsy mp-MRI? [2023]Multi-parametric magnetic resonance imaging (mp-MRI) is currently used to triage patients with suspected prostate cancer, before deciding on prostate biopsies. In our study, we evaluated normal and equivocal pre-biopsy mp-MRIs to see whether it is safe to avoid biopsy with such findings.
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]The role of multiparametric magnetic resonance imaging (mp-MRI) during active surveillance (AS) of prostate cancer needs evaluation. It remains unclear whether mp-MRI can replace prostate biopsies completely during AS.
The future direction of imaging in prostate cancer: MRI with or without contrast injection. [2022]Multiparametric MRI (mpMRI) is the "state of the art" management tool for patients with suspicion of prostate cancer (PCa). The role of non-contrast MRI is investigated to move toward a more personalized, less invasive, and highly cost-effective PCa diagnostic workup.