Status:
RECRUITING
Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Myrexis Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 futur...
Detailed Description
All patients in this study have received or will receive a score from the Michigan Urological Surgery Improvement Collaborative's Cancer of the Prostate Risk Assessment (askMUSIC) scoring system, at t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2031
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04396808
Start Date
November 5 2020
End Date
April 30 2031
Last Update
January 7 2026
Active Locations (8)
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1
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
2
Henry Ford Health System
Detroit, Michigan, United States, 48202
3
Sherwood Medical Center
Detroit, Michigan, United States, 48221
4
Spectrum Health Medical Group
Grand Rapids, Michigan, United States, 49503