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NCT03784924Recruiting

EDRN Prostate MRI Biomarker Study

EDRN Prostate MRI Biomarker Study and Reference Set

Source: ClinicalTrials.gov · Last updated 17 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
950 (estimated)
First submitted
4 Dec 2018
Start date
4 Feb 2019
Primary completion date
30 Jun 2028
Lead sponsor
University of Michigan
NCT number
NCT03784924

What you commit to

  • Study type: Observational
  • Planned participants: 950
  • From 4 Feb 2019 to the primary completion date, 30 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • Prior prostate surgery such as TURP, TUNA, TUMT, HOLEP, REZUM, UROlift
  • Prior PCA3, TMPRSS2:erg or MIPS panel performed for clinical purpose

Other illness

  • Unable to undergo/tolerate a prostate MRI or failure to conduct the MRI
  • Participating in clinical trial for prostate disease

Other

  • Inability to obtain blood and urine per SOP or conduct an attentive DRE

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.