Status:
TERMINATED
Evaluation of a Blood Biomarker to Try and Distinguish Between the Presence or Absence of Aggressive Prostate Cancer
Lead Sponsor:
Genomic Health®, Inc.
Collaborating Sponsors:
AdventHealth
Conditions:
Prostate Cancer
Eligibility:
MALE
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03256630
Start Date
January 10 2018
End Date
February 28 2019
Last Update
February 5 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Florida Hospital Global Robotics Institute
Celebration, Florida, United States, 34747