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

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Northwestern University, Chicago, IL
Prostate Cancer+1 More
Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostate - Other
Eligibility
18+
Male
What conditions do you have?
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Study 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.

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 18 months after diagnostic prostate biopsy

Month 18
Proportion of men who had an active surveillance prostate biopsy by 18 months
The proportion of men with reclassification within 18 months

Trial Safety

Trial Design

1 Treatment Group

Genomic Prostate Score assay and multi-parametric MRI of the prostate
1 of 1
Experimental Treatment

222 Total Participants · 1 Treatment Group

Primary Treatment: Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostate · No Placebo Group · N/A

Genomic Prostate Score assay and multi-parametric MRI of the prostate
Other
Experimental Group · 1 Intervention: Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostate · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months after diagnostic prostate biopsy

Trial Background

Prof. Adam Murphy, Assistant Professor of Urology and Preventive Medicine
Principal Investigator
Northwestern University
Closest Location: Northwestern University · Chicago, IL
Photo of Northwestern University  1Photo of Northwestern University  2Photo of Northwestern University  3
1993First Recorded Clinical Trial
25 TrialsResearching Prostate Cancer
1040 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Male Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Participants must have NCCN very low to favorable intermediate risk prostate cancer.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.