EMBRACE1: Prostate Biorepository

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Caris Science, Inc.

Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Carisome Prostate Assay with prostate biopsy outcome

Time frame: up to 6 months

Association of Carisome Prostate Assay result with prostate biopsy outcome

Sponsors and collaborators

Lead sponsor

Caris Science, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Dec 26, 2011
Registry last updated: Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed