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EDRN PROSTATE MRI BIOMARKER STUDY AND REFERENCE SET

Primary Investigator
Wei, John
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT03784924
UM Number
00148970
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Genitourinary Oncology
ID (Protocol)
13300
Secondary Protocol No
HUM00148970
Scope
Unspecified
Sponsor Type
Externally Peer-Reviewed
Disease Site
Prostate
Summary
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.

Eligibility: 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