NCT01499381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

7 months

First QC Date

December 16, 2011

Last Update Submit

June 7, 2016

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Carisome Prostate Assay with prostate biopsy outcome

    Association of Carisome Prostate Assay result with prostate biopsy outcome

    up to 6 months

Study Arms (1)

Routine prostate biopsy patients

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men scheduled for routine prostate biopsy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caris Science, Inc.

Phoenix, Arizona, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2011

First Posted

December 26, 2011

Study Start

December 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

June 9, 2016

Record last verified: 2016-06

Locations

US(1)