RecruitingNot ApplicableNCT04396808

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

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

Sponsor

University of Michigan Rogel Cancer Center

Enrollment

900 participants

Start Date

Nov 5, 2020

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses genomic testing of prostate cancer tissue to help guide treatment decisions for men with newly diagnosed, early-stage (favorable risk) prostate cancer. The goal is to see whether genetic information from the biopsy can improve how doctors and patients choose between active surveillance and active treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with prostate cancer via biopsy in the past 9 months - Your PSA level is below 20 ng/mL - Your cancer is low-to-intermediate risk (Grade Group 1 with more than 2 positive biopsy cores, or Grade Group 2) - Biopsy tissue is available for genetic testing **You may NOT be eligible if...** - Your cancer has grown beyond the prostate (T3 or higher on exam or MRI) - Your cancer has spread to lymph nodes or other organs - You have already received prostate cancer treatment (surgery, radiation, or hormone therapy) - You have already had prostate genetic testing done (a gene expression classifier) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDecipher

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.

DEVICEProlaris

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.

DEVICEOncotype 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.

OTHERStandard 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.