EMBRACE1: Prostate Biorepository

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT01499381
• Lead Sponsor: Caris Science, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-23
• Study First Posted: 2011-12-26
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-07
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1290

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Carisome Prostate Assay with prostate biopsy outcome	up to 6 months	Association of Carisome Prostate Assay result with prostate biopsy outcome

Trial Locations

Locations (1)

Caris Science, Inc.; 🇺🇸 Phoenix, Arizona, United States