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RECRUITING
NCT04396808
NA

Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer

Sponsor: University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

Summary

This study seeks to determine the clinical impact of Gene Expression Classifier (GEC) testing in prostate cancer care while also developing a pragmatic approach for improved GEC clinical use and future study.

Official title: Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR): A Randomized Multi-center Study for Men With Newly Diagnosed Favorable Risk Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2020-11-05

Completion Date

2031-04-30

Last Updated

2026-01-07

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Decipher

The Decipher test (GenomeDx Biosciences) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision.

DEVICE

Prolaris

The Prolaris test (Myriad Genetics, Inc.) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision.

DEVICE

Oncotype Dx Genomic Prostate Score (GPS)

The Oncotype Dx GPS test (Exact Sciences corp.) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision.

OTHER

Standard of care (askMUSIC score)

AskMUSIC is a risk calculator based on standard clinical and pathologic variables (https://ask.musicurology.com/) and is generally included as part of routine clinical care.

Locations (8)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Sherwood Medical Center

Detroit, Michigan, United States

Spectrum Health Medical Group

Grand Rapids, Michigan, United States

Western Michigan Urological Associates

Holland, Michigan, United States

Montefiore Medical Center

The Bronx, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, United States