EDRN Prostate MRI Biomarker Study
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/14/2019 |
| Start Date: | February 4, 2019 |
| End Date: | February 4, 2024 |
| Contact: | Jackie Dahlgren |
| Email: | jdahlgre@fredhutch.org |
| Phone: | 206-667-3438 |
EDRN Prostate MRI Biomarker Study and Reference Set
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.
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.
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.
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.
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
- 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
We found this trial at
1
site
University of Michigan The University of Michigan was founded in 1817 as one of the...
Click here to add this to my saved trials
