A Laboratory Study To Evaluate A Blood Biomarker That Can Distinguish Between the Presence Or Absence of Aggressive Prostate Cancer

Genomic Health®, Inc.1 site in 1 country128 target enrollmentJanuary 10, 2018

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Genomic Health®, Inc.
Enrollment: 128
Locations: 1
Primary Endpoint: Characterize the distribution of clinical/pathological factors of the samples by the Gleason Grade Group and to characterize the distribution of the signal of each biomarker by the Gleason Grade Group or combination of groups.
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A Laboratory Study to Evaluate Urine and Blood Biomarkers That Can Distinguish Between the Presence or Absence of Aggressive Prostate Cancer

Detailed Description

The over-arching goal of this study is to evaluate if biomarkers within the blood or urine of men with localized prostate cancer can distinguish between those with indolent cancer, defined as Gleason Grade Groups 1 and 2 and those with more aggressive disease (Gleason Grade Groups 3, 4, and 5).

Registry

clinicaltrials.gov

Start Date

January 10, 2018

End Date

February 28, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Genomic Health®, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient has been diagnosed with Prostate Cancer and is planning on having a Radical Prostatectomy performed at the Global Robotics Institute.
•Diagnostic PSA ≤ 20 ng/mL.
•Pathology report from most recent positive biopsy, prior to Radical Prostatectomy, is available.
•Ability to read and understand the informed consent form.
•Patient must have signed informed consent form

Exclusion Criteria

•Any of the following active therapies received: radiation, chemotherapy, biologic agents, surgery, local therapies including cryotherapy or HIFU.
•Diagnostic PSA \> 20 ng/mL or missing PSA.
•Patients who are unable or unwilling to provide informed consent.

Outcomes

Primary Outcomes

Characterize the distribution of clinical/pathological factors of the samples by the Gleason Grade Group and to characterize the distribution of the signal of each biomarker by the Gleason Grade Group or combination of groups.

Time Frame: 1 year