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EDRN Prostate MRI Biomarker Study

RECRUITINGSponsored by University of Michigan
Actively Recruiting
SponsorUniversity of Michigan
Started2019-02-04
Est. completion2028-06-30
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions3

CancerPSAProstate Cancer

Locations1 site

University of Michigan
Ann Arbor, Michigan, 48109
John T Wei, MD7346153040jtw@med.umich.edu

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