EMBRACE1: Prostate Biorepository
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | December 2011 |
| End Date: | July 2012 |
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
The objective of this multi-center prospective observational clinical study is to evaluate
the clinical performance of the Carisome Prostate assay as an aid in the diagnosis of
prostate cancer in men that have been scheduled for a prostate biopsy. Primarily, results
of the Carisome Prostate assay will be compared with pathology results of prostate biopsy
procedures. Secondarily, the performance of the Carisome Prostate test will be compared to
the current standard of care for the detection of prostate cancer.
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
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