EMBRACE1: Prostate Biorepository

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01499381

Enrollment

1290

Registered

2011-12-26

Start date

2011-12-31

Completion date

2012-07-31

Last updated

2016-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Carisome Prostate Assay with prostate biopsy outcome	up to 6 months	Association of Carisome Prostate Assay result with prostate biopsy outcome

Countries

United States

Outcome results