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

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

Interventions

OTHER

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

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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Northwestern University

  lead OTHER

Eligibility

Min Age

40 Years

Max Age

76 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-15

Primary Completion

2026-06-30

Completion

2026-12-31

Countries

• United States

Study Locations