NCT05608694

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
156mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Mar 2022Mar 2039

Study Start

First participant enrolled

March 2, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
14.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2037

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2039

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

15 years

First QC Date

October 10, 2022

Last Update Submit

February 27, 2026

Conditions

Prostate Cancer Screening

Outcome Measures

Primary Outcomes (1)

  • 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).

    Every 3 years up to 15 years

Study Arms (4)

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.

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.

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).

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.

Other: Prostate MRI

Interventions

Prostate MRIOTHER

Group placement is determined by GRS score, Family history, and germline testing

High Risk- Family History (n=45):High Risk- High GRS (n=40):High Risk- Positive Germline Mutation (n=40):Low Risk (n=125):

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male age 18 and older
  • No known history of prostate cancer
  • No previous prostate resection or ablation (e.g. TURP, photovaporization)

You may not qualify if:

  • Unable to tolerate MRI due to metal fragments or claustrophobia
  • Lack of a rectum
  • Hip arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

NorthShore University Health System - Glenbrook Hospital

Glenview, Illinois, 60026, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 38576242BACKGROUND

  • Hugosson 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.

    PMID: 39321360BACKGROUND

  • Bjornebo 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.

    PMID: 38648061BACKGROUND

Study Officials

  • Scott Eggener, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Eggener, MD

CONTACT

7737021001seggener@surgery.bsd.uchicago.edu

Teresa Barry

CONTACT

tbarry@bsd.uchicago.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2022

First Posted

November 8, 2022

Study Start

March 2, 2022

Primary Completion (Estimated)

March 1, 2037

Study Completion (Estimated)

March 1, 2039

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

US(2)