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EDRN Prostate MRI Biomarker Study
Trial Status: active
The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the
use of MRI imaging for prostate cancer. How best to use MRI in the initial prostate
biopsy setting given the availability of validated prostate cancer early detection
markers is uncertain.This study will allow investigators to determine if prostate MRI is
superior to validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in
the initial biopsy setting.
Inclusion Criteria
Men with suspected but undiagnosed prostate cancer
To be scheduled/scheduled for biopsy as routine clinical care
Exclusion Criteria
Inability to obtain blood and urine per SOP or conduct an attentive DRE
Unable to undergo/tolerate a prostate MRI or failure to conduct the MRI
Prior diagnosis of prostate cancer
Prior prostate MRI unless being used as Index MRI (in this case index MRI can be one year prior to consent date)
Participating in clinical trial for prostate disease
Prior prostate surgery such as TURP, TUNA, TUMT, HOLEP, REZUM, UROlift
Prior PCA3, TMPRSS2:erg or MIPS panel performed for clinical purpose
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03784924.
