Clinical trial NCT03784924: EDRN Prostate MRI Biomarker Study
Official title: EDRN Prostate MRI Biomarker Study and Reference Set
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PSA
Prostate Cancer
Keywords: Prostate cancer
psa
early detection
MRI
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
name: University of Alabama at Birmingham
name: University of Chicago
name: Cornell University
name: H. Lee Moffitt Cancer Center and Research Institute
name: Vanderbilt University
name: Emory University
name: University of Miami
name: University of Texas
name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: Fred Hutchinson Cancer Center
First posted: 2018-12-24
Enrollment: 950
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urology clinics

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.

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.

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

Primary outcomes:
measure: Clinically significant prostate cancer
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: John T Wei, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: