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Recruiting NCT04396808

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

Trial Parameters

Condition Prostate Cancer
Sponsor University of Michigan Rogel Cancer Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 900
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2020-11-05
Completion 2028-04-30
Interventions
DecipherProlarisOncotype Dx Genomic Prostate Score (GPS)

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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

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