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Recruiting NCT03784924

EDRN Prostate MRI Biomarker Study

— Observational PSA Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI prostate.
Who it may be relevant to
Registry conditions: PSA, Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

EDRN Prostate MRI Biomarker Study and Reference Set

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.

Detailed description

The primary aim of this study is to see if the addition of prostate MRI to a panel consisting of PSA, PCA3, TMPRSS2:ERG will significantly improve specificity for high-grade prostate cancer by 10%. The subsequent exploratory aims will 1) create an optimal panel of urine, blood and tissue biomarkers that will select those cases most likely to benefit from a MRI targeted biopsy, 2) directly compare PSA and urinary biomarkers with MRI to determine which ones are value added in the setting of initial biopsy, 3) evaluate changes in these biomarkers and MRI to determine if longitudinal changes predict subsequent high-grade prostate cancer, and 4) optimize MRI imaging to improve test performance. Importantly, this study will create a unique, prospective, cohort that will become the foundational reference set for of a range of future biomarker studies.

Interventions

  • Diagnostic test MRI prostate
    MRI and laboratory biomarkers

Primary outcome measures

  • Clinically significant prostate cancer [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT03784924 · 430

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗