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

RECRUITINGN/ASponsored by University of Michigan Rogel Cancer Center
Actively Recruiting
PhaseN/A
SponsorUniversity of Michigan Rogel Cancer Center
Started2020-11-05
Est. completion2028-04-30
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations8 sites
View on ClinicalTrials.gov →

NCT04396808

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

Locations8 sites

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
G-Major Study734-764-4060gmajorstudy@med.umich.edu
Henry Ford Health System
Detroit, Michigan, 48202
Craig Rogers, MD
Sherwood Medical Center
Detroit, Michigan, 48221
Conrad Maitland, MD
Spectrum Health Medical Group
Grand Rapids, Michigan, 49503
Conrad Tobert
Western Michigan Urological Associates
Holland, Michigan, 49423
John Ludlow, MD

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