NCT03256630TerminatedNot Applicable
A Laboratory Study To Evaluate A Blood Biomarker That Can Distinguish Between the Presence Or Absence of Aggressive Prostate Cancer
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- 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.
Study 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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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