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

Genomic Health®, Inc.128 enrolled

Overview

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

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

128

Conditions

Prostate Cancer

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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.

Locations (1)

Florida Hospital Global Robotics Institute

Celebration, Florida, United States

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

Data from ClinicalTrials.gov

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