Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Routine prostate biopsy patients
Primary outcomes (1)
- measure
- Carisome Prostate Assay with prostate biopsy outcome
- timeFrame
- up to 6 months
- description
- Association of Carisome Prostate Assay result with prostate biopsy outcome
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available