EMBRACE1: Prostate Biorepository

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01499381
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : June 9, 2016
Information provided by (Responsible Party):
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.

Condition or disease
Prostate Cancer

Study Type : Observational
Actual Enrollment : 1290 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : December 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Routine prostate biopsy patients

Primary Outcome Measures :
  1. Carisome Prostate Assay with prostate biopsy outcome [ Time Frame: up to 6 months ]
    Association of Carisome Prostate Assay result with prostate biopsy outcome

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men scheduled for routine prostate biopsy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01499381

United States, Arizona
Caris Science, Inc.
Phoenix, Arizona, United States
Sponsors and Collaborators
Caris Science, Inc.

Responsible Party: Caris Science, Inc. Identifier: NCT01499381     History of Changes
Other Study ID Numbers: CRMDA-0001-1011
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases