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Clinical Trial 20094

Cancer Type: Multiple
Study Type: Screening
NCT#: NCT03784924

Phase: N/A
Prinicipal Investigator: Julio Pow-Sang

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or 1-800-679-0775 Learn More
Overview

Study Title

EDRN Prostate MRI Biomarker Study and Reference Set

Summary

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.

Objective

The overarching goal of EDRN protocol is to evaluate whether prostate MRI with other biomarker panel from Urine and serum (PSA, PCA3, TMPRSS2:ERG) will significantly improve specificity (up to 10%) to identify high-grade prostate cancer.

Treatments

Therapies

Medications

Inclusion Criteria

Inclusion Criteria:

  • Men at least 18 years old with suspected but undiagnosed prostate cancer
  • To be scheduled/scheduled for biopsy as routine clinical care

  • Exclusion Criteria

    Exclusion Criteria:

  • Inability to obtain blood and urine per SOP or conduct an attentive DRE urine per SOP (at least 2 post-DRE whole urine samples must be collected)
  • 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 which case the index MRI can be up to one year prior to consent
  • 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
  • Bilateral hip replacement

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