Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed… (NCT04396808) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer
United States805 participantsStarted 2020-11-05
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Binomial proportion of men on active surveillance without treatment