Brief 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.
Brief Title
EDRN Prostate MRI Biomarker Study
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
206-667-3438
Central Contact Email
jdahlgre@fredhutch.org
Completion Date
Completion Date Type
Estimated
Conditions
PSA
Prostate Cancer
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Men with suspected but undiagnosed prostate cancer
* To be scheduled/scheduled for biopsy as routine clinical care
* Men with suspected but undiagnosed prostate cancer
* To be scheduled/scheduled for biopsy as routine clinical care
Gender
Male
Gender Based
false
Keywords
Prostate cancer
psa
early detection
MRI
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03784924
Org Class
Other
Org Full Name
University of Michigan
Org Study Id
430
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
EDRN Prostate MRI Biomarker Study and Reference Set
Primary Outcomes
Outcome Description
Pathologic diagnosis of prostate cancer with at least Gleason 7 or worse cancer grade on a needle biopsy
Outcome Measure
Clinically significant prostate cancer
Outcome Time Frame
2 years
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Urology clinics
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kara Watts
Investigator Email
kwatts@montefiore.org
Investigator Phone
kwatts