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

Genomic Health

Status: Terminated

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03256630

09-048

Details and patient eligibility

About

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

Full 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).

Enrollment: 128 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.