EMBRACE1: Prostate Biorepository

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499381
• Other study ID #: CRMDA-0001-1011
• Status: Completed
• Phase: N/A
• First received: December 16, 2011
• Last updated: June 7, 2016
• Start date: December 2011
• Est. completion date: July 2012

Study information

• Verified date: June 2016
• Source: Caris Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1290
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Caris Science, Inc.	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Caris Science, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carisome Prostate Assay with prostate biopsy outcome	Association of Carisome Prostate Assay result with prostate biopsy outcome	up to 6 months	No