Evaluation of a Novel Circulating Microvesicle-Based Multi-analyte Assay for the Detection of Prostate Cancer in Men With Elevated Risk for Prostate Cancer; the EMBRACE1 Study
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
Evaluation of a Novel Circulating Microvesicle-Based Multi-analyte Assay for the Detection of Prostate Cancer in Men With Elevated Risk for Prostate Cancer; the EMBRACE1 Study
Inclusion Criteria:
- Men scheduled for a routine prostate biopsy expected to produce a pathology
evaluation and report
- Blood draw within 7 days prior to scheduled prostate biopsy procedure
- Blood draw on the day of but prior to biopsy
Exclusion Criteria:
- Any previous diagnosis of cancer with the exception of non-melanoma skin cancer
- Any prior or ongoing treatment for prostate cancer including prostatectomy or hormone
therapy
- Prostate biopsy within one month of blood draw
- Previous enrollment in the Caris Life Sciences Biorepository
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Carisome Prostate Assay with prostate biopsy outcome
Outcome Description:
Association of Carisome Prostate Assay result with prostate biopsy outcome
Outcome Time Frame:
up to 6 months
Safety Issue:
No
Principal Investigator
Les Paul, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Caris Science, Inc.
Authority:
United States: Institutional Review Board
Study ID:
CRMDA-0001-1011
NCT ID:
NCT01499381
Start Date:
December 2011
Completion Date:
July 2012
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Caris Science, Inc. | Phoenix, Arizona |
