EDRN Prostate MRI Biomarker Study

Trial ID or NCT#

NCT03784924

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

EDRN Prostate MRI Biomarker Study and Reference Set

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Men with suspected but undiagnosed prostate cancer - To be scheduled/scheduled for biopsy as routine clinical care
Exclusion Criteria:
  1. - 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
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Investigator(s)

Geoffrey Sonn
Geoffrey Sonn
Urologic oncologist, Urologist, Urologic specialist, Genitourinary specialist, Urologic surgeon
Associate Professor of Urology and, by courtesy, of Radiology (Body MRI)

Contact us to find out if this trial is right for you.

Contact

Daniel Alvarez
650-723-0948

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View on ClinicalTrials.gov