Clinical trial NCT05608694: MRI Screening in Men at High Risk of Developing Prostate Cancer
Official title: MRI Screening in Men at High Risk of Developing Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer Screening
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of patients with high grade prostate cancer detection.
timeFrame: Every 3 years up to 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Glenview
country: United States
facility: NorthShore University Health System - Glenbrook Hospital
state: Illinois
Study officials:
affiliation: University of Chicago
name: Scott Eggener, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.