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

Inclusion Criteria6

Prostate cancer patients who have undergone diagnostic prostate biopsy in the past 9 months.
Prostate biopsy tumor tissue (FFPR block) available for processing
Age 18 years or older
PSA \<20 ng/ml
Grade Group (GG) 1 cancer with \> 2 biopsy cores involved with cancer OR GG2 cancer
Ability to understand and the willingness to sign a written informed consent. A subject's legally acceptable representative may sign the consent form.

Exclusion Criteria4

Clinical (on digital rectal exam) or radiographic evidence (if MRI performed) of T3 disease
Nodal or metastatic prostate cancer (if staging imaging performed)
Prior prostate cancer treatment, including prostatectomy, radiation therapy, or hormone therapy.
Prior prostate gene expression classier testing

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.