EDRN Prostate MRI Biomarker Study

Description

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.

Conditions

PSA, Prostate Cancer

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Study Overview

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Study Details

Study overview

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.

EDRN Prostate MRI Biomarker Study and Reference Set

EDRN Prostate MRI Biomarker Study

Condition
PSA
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Men with suspected but undiagnosed prostate cancer
  • * To be scheduled/scheduled for biopsy as routine clinical care
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

John T Wei, MD, MS, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2028-12-31