Evaluation of a Blood Biomarker to Try and Distinguish Between the Presence or Absence of Aggressive Prostate Cancer

February 3, 2020 updated by: Genomic Health®, Inc.

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

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

Study Overview

Status

Terminated

Conditions

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).

Study Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Celebration, Florida, United States, 34747
        • Florida Hospital Global Robotics Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Prostate cancer patients who are planning to have a Radical Prostatectomy at the Global Robotics Institute and are informed and willing to participate in study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genomic Health®, Inc.

Collaborators

AdventHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

December 20, 2018

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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