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Genomics in Michigan to AdJust Outcomes in prostate canceR (G-MAJOR): A randomized controlled multi-center study for men with newly diagnosed favorable risk prostate cancer

Primary Investigator
Morgan, Todd
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT04396808
UM Number
2019.132
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Genitourinary Oncology
ID (Protocol)
16239
Secondary Protocol No
HUM00173277
Scope
Unspecified
Sponsor Type
National
Disease Site
Prostate
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: 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