MRI And GPS Informing Choices for Prostate Cancer Treatment (MAGIC)

NCT05424783 | Recruiting DMC

• 1 other identifier: STU00215555
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 2

Brief Summary

The overarching goal is to prospectively recruit men considering active surveillance for treatment in the MAGIC (MRI And GPS Informing Choices for prostate cancer treatment) Cohort to provide meaningful data on active surveillance in Blacks and in men served in safety net hospitals. Recent studies highlight significant promise for multi-parametric magnetic resonance imaging of the prostate (MRI) and Genomic Prostate Score assay (GPS) as tools to help risk stratify men on active surveillance to identify men likely to harbor undetected aggressive disease in their prostate. Given the risk data provided by these modalities and the low adherence with monitoring common in men served in public hospitals, both tools may improve safety via improved patient selection and patient adherence with monitoring. The downside is that excessive testing may lead to too many false positives and unnecessary treatment. Two hundred men with very low to intermediate risk prostate cancer were randomized into the 2-arm ENACT Clinical trial from 2016-2019 to study the impact of the GPS assay on treatment choice. Overall, 104 men received GPS assay and 96 controls did not receive the assay (a confirmatory test) right after being newly diagnosed with favorable risk prostate cancer. For Aim 1, 222 men will be recruited into the MRI And GPS Informing Choices for prostate cancer treatment (MAGIC) study and they will be given the GPS assay and multi-parametric MRI of the prostate to provide personalized risk data for having aggressive tumors in their prostate. Between the ENACT and MAGIC study, there will be 3 groups of men who will have received both GPS \& MRI, GPS alone, or neither test and can compare the impact of having 0,1 or 2 confirmatory tests on patient's adherence to active surveillance monitoring protocols over 18 months. The analyses will elucidate whether 1 or 2 tests are needed to improve adherence to monitoring. Monitoring is vital for detecting tumor progression early and avoiding cancer metastasis and death. In Aim 2, the MAGIC study cohort will be leveraged to determine the accuracy of the Genomic Prostate Score assay and the prostate imaging- reporting and data system (PIRADS) score from the MRI in predicting which tumors will progress in 18 months. Progression is defined as increased Gleason grade group (GG) or change in prostate digital rectal examination findings. This serves two purposes. It will allow doctors and patients to categorize the patient as safe or risky for active surveillance. Secondly, it will allow doctors to identify which men on active surveillance need to be followed with annual prostate biopsies and which men can have their biopsies deferred for 3-5 years to reduce the number of prostate biopsies and their morbidities. Lastly in Aim 3, the participants will rank the importance of these tests among a multitude of clinical, social, financial and interpersonal influences on their cancer treatment choice. By tallying the patient rankings, one can identify the most critical decision making factors that can be used to encourage increased selection of active surveillance.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of men who had an active surveillance prostate biopsy by 18 months

  The men in the MAGIC study who chose active surveillance that complete their active surveillance prostate biopsy by 18 months after their diagnostic prostate biopsy will be compared to men who chose active surveillance in the ENACT Clinical Trial who received GPS alone (ENACT intervention arm) or neither GPS nor prostate MRI (ENACT control arm).

  18 months after diagnostic prostate biopsy

Secondary Outcomes (1)

• The proportion of men with reclassification within 18 months

  18 months after diagnostic prostate biopsy

Study Arms (1)

Genomic Prostate Score assay and multi-parametric MRI of the prostate

Men with newly diagnosed NCCN very low to favorable intermediate risk prostate cancer will be enrolled at their post biopsy urologist visit. Once enrolled, participants will have their prostate tissue sent off for their Genomic Prostate Score assay and men will undergo a prostate MRI to evaluate for potentially missed clinically significant prostate cancer. In a subsequent urologist visit, participants will choose their treatment choice. Men who choose active surveillance for their primary treatment choice will be monitored per clinical routine by PSA, digital rectal exam, and active surveillance prostate biopsy in 12-18 months. After month 6, men will be followed through their electronic medical records system to track adherence to their 12-18 month active surveillance prostate biopsy.

Other: Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostate

Interventions

Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostate OTHER

The Genomic Prostate Score is a 17 gene relative expression assay used to predict the presence of adverse pathologic findings at radical prostatectomy. This test is used to determine appropriateness for active surveillance. Prostate MRI is a prostate imaging test that has been shown to improve the detection of clinically significant prostate cancer using a PI-RADS scoring system. It relies on T2-weighted imaging, diffusion weighted imaging, dynamic contrast enhancement, and apparent diffusion coefficient to differentiate prostate cancer from normal prostate parenchyma and prostatitis.

Also known as: GPS assay + mp-MRI

Genomic Prostate Score assay and multi-parametric MRI of the prostate

Eligibility Criteria

• Age: 40 Years - 76 Years
• Gender Eligibility Details: Cis-gender men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population for this study is participants with newly diagnosed favorable risk prostate cancer who are eligible for active surveillance for Prostate Cancer.

You may qualify if:

• Participants must have NCCN very low to favorable intermediate risk prostate cancer.
• Participants must be diagnosed within 3 months prior to study enrollment.
• Participants must be male, age 40-76 years old.
• Participants must be willing to consider active surveillance for treatment.

You may not qualify if:

• Participants with less than 10 years life expectancy.
• Participants unable to complete standardized surveys.
• Participants with no access to the rectum for a transrectal ultrasound.
• Participants with a contraindication to magnetic resonance imaging (MRI).

Sponsors & Collaborators

• Northwestern University: lead
• United States Department of Defense: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

ACTIVE NOT RECRUITING

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Adam B Murphy, MD,MBA,MSCI

CONTACT

312-908-2002; a-murphy2@northwestern.edu

Daniel Moreira, MD

CONTACT

919-308-0332; moreira@uic.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: October 15, 2022
• Primary Completion: June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 18 months after study completion
• Access Criteria: Affiliated with a research institution and proof of human subjects research training.

Locations

US (2)