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

Conditions

• Prostate Cancer

Interventions

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.

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.

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.

Sponsors & Collaborators

• MDx Health

  collaborator INDUSTRY

• National Cancer Institute (NCI)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Myrexis Inc.

  collaborator INDUSTRY

• Veracyte, Inc.

  collaborator INDUSTRY

• University of Michigan Rogel Cancer Center

  lead OTHER

Principal Investigators

• Todd Morgan, M.D. · University of Michigan

• Daniel Spratt, M.D. · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-05

Primary Completion

2028-03-31

Completion

2031-03-31

Countries

• United States

Study Locations