Prostate Cancer ScreeningNCT05608694
MRI Screening in Men at High Risk of Developing Prostate Cancer
A study testing Prostate MRI in people with Prostate Cancer Screening, run by University of Chicago at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Screening
- What is being tested?
- Prostate MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Mar 2022to 1 Mar 2039
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male age 18 and older
- No known history of prostate cancer
- No previous prostate resection or ablation (e.g. TURP, photovaporization)
Who cannot join
- Unable to tolerate MRI due to metal fragments or claustrophobia
- Lack of a rectum
- Hip arthroplasty
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago
Chicago, Illinois, 60637
NorthShore University Health System - Glenbrook Hospital
Glenview, Illinois, 60026
About this study
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.
Read the detailed description
In this study the study team hypothesizes MR images will identify high-grade cancers earlier and more frequently in men at high risk of developing prostate cancer. Subjects will receive gadolinium (intravenous contrast agent) as part of their research MRI exam. While the deposition of gadolinium (Gd) has been demonstrated in numerous studies, the clinical consequences of Gd deposition are unknown. Gd enhanced MRI scans provide crucial medical information regarding prostate and prostate cancer imaging and contrast-enhanced images are a component of all guidelines and the PIRADS scoring system. The study team will compare baseline prostate MR images of men at high risk of developing prostate cancer to those without an identifiable predisposition and evaluate the role of a GRS in screening men with at elevated risk of being diagnosed with prostate cancer.
- Conditions
- Prostate Cancer Screening
- Being tested
- Prostate MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate MRIOther
Group placement is determined by GRS score, Family history, and germline testing
| Study group | Role | What they receive |
|---|---|---|
| High Risk- Positive Germline Mutation (n=40): | Other | 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. Receives: Other: Prostate MRI |
| High Risk- High GRS (n=40): | Other | 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. Receives: Other: Prostate MRI |
| High Risk- Family History (n=45): | Other | 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). Receives: Other: Prostate MRI |
| Low Risk (n=125): | Other | No known germline mutation, low genetic risk score (GRS <1.5), and no known family history of prostate cancer. Receives: Other: Prostate MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with high grade prostate cancer detection.
MRI results will be collected every 3 years for 15 years until high grade prostate cancer is detected as defined as Gleason greater than or equal to 7 (Grade Group 2).
Measured: Every 3 years up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start2 Mar 2022
- Primary completion1 Mar 2037 (estimated)
- Study completion1 Mar 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhinav Sidana, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608694
- Sponsor's protocol ID
- IRB20-0038
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fazekas T, Shim SR, Basile G, Baboudjian M, Koi T, Przydacz M, Abufaraj M, Ploussard G, Kasivisvanathan V, Rivas JG, Gandaglia G, Szarvas T, Schoots IG, van den Bergh RCN, Leapman MS, Nyirady P, Shariat SF, Rajwa P. Magnetic Resonance Imaging in Prostate Cancer Screening: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 Jun 1;10(6):745-754. doi: 10.1001/jamaoncol.2024.0734.
PubMed 38576242Hugosson J, Godtman RA, Wallstrom J, Axcrona U, Bergh A, Egevad L, Geterud K, Khatami A, Socratous A, Spyratou V, Svensson L, Stranne J, Mansson M, Hellstrom M. Results after Four Years of Screening for Prostate Cancer with PSA and MRI. N Engl J Med. 2024 Sep 26;391(12):1083-1095. doi: 10.1056/NEJMoa2406050.
PubMed 39321360Bjornebo L, Discacciati A, Falagario U, Vigneswaran HT, Jaderling F, Gronberg H, Eklund M, Nordstrom T, Lantz A. Biomarker vs MRI-Enhanced Strategies for Prostate Cancer Screening: The STHLM3-MRI Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e247131. doi: 10.1001/jamanetworkopen.2024.7131.
PubMed 38648061
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Screening in Men at High Risk of Developing Prostate Cancer
- ClinicalTrials.gov ID
- NCT05608694
- Acronym / sponsor ID
- IRB20-0038
- Conditions
- Prostate Cancer Screening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 1 Mar 2037 (estimated)
- Study completion
- 1 Mar 2039 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study the study team hypothesizes MR images will identify high-grade cancers earlier and more frequently in men at high risk of developing prostate cancer. Subjects will receive gadolinium (intravenous contrast agent) as part of their research MRI exam. While the deposition of gadolinium (Gd) has been demonstrated in numerous studies, the clinical consequences of Gd deposition are unknown. Gd enhanced MRI scans provide crucial medical information regarding prostate and prostate cancer imaging and contrast-enhanced images are a component of all guidelines and the PIRADS scoring system. The study team will compare baseline prostate MR images of men at high risk of developing prostate cancer to those without an identifiable predisposition and evaluate the role of a GRS in screening men with at elevated risk of being diagnosed with prostate cancer.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Risk- Positive Germline Mutation (n=40): | Other | Other: Prostate MRIMen 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. |
| High Risk- High GRS (n=40): | Other | Other: Prostate MRIMen 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. |
| High Risk- Family History (n=45): | Other | Other: Prostate MRIMen 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). |
| Low Risk (n=125): | Other | Other: Prostate MRINo known germline mutation, low genetic risk score (GRS <1.5), and no known family history of prostate cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male age 18 and older
- No known history of prostate cancer
- No previous prostate resection or ablation (e.g. TURP, photovaporization)
Key exclusion criteria (3 listed)
- Unable to tolerate MRI due to metal fragments or claustrophobia
- Lack of a rectum
- Hip arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate MRIGroup placement is determined by GRS score, Family history, and germline testing | Other | High Risk- Family History (n=45):, High Risk- High GRS (n=40):, High Risk- Positive Germline Mutation (n=40):, Low Risk (n=125): |
Primary outcome
Proportion of patients with high grade prostate cancer detection.
Time frame: Every 3 years up to 15 years
MRI results will be collected every 3 years for 15 years until high grade prostate cancer is detected as defined as Gleason greater than or equal to 7 (Grade Group 2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 38576242Fazekas T, Shim SR, Basile G, Baboudjian M, Koi T, Przydacz M, Abufaraj M, Ploussard G, Kasivisvanathan V, Rivas JG, Gandaglia G, Szarvas T, Schoots IG, van den Bergh RCN, Leapman MS, Nyirady P, Shariat SF, Rajwa P. Magnetic Resonance Imaging in Prostate Cancer Screening: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 Jun 1;10(6):745-754. doi: 10.1001/jamaoncol.2024.0734.
- Background: PubMed 39321360Hugosson J, Godtman RA, Wallstrom J, Axcrona U, Bergh A, Egevad L, Geterud K, Khatami A, Socratous A, Spyratou V, Svensson L, Stranne J, Mansson M, Hellstrom M. Results after Four Years of Screening for Prostate Cancer with PSA and MRI. N Engl J Med. 2024 Sep 26;391(12):1083-1095. doi: 10.1056/NEJMoa2406050.
- Background: PubMed 38648061Bjornebo L, Discacciati A, Falagario U, Vigneswaran HT, Jaderling F, Gronberg H, Eklund M, Nordstrom T, Lantz A. Biomarker vs MRI-Enhanced Strategies for Prostate Cancer Screening: The STHLM3-MRI Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e247131. doi: 10.1001/jamanetworkopen.2024.7131.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhinav Sidana, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate MRI in people with Prostate Cancer Screening, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with high grade prostate cancer detection. (time frame: Every 3 years up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05608694, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.