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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03256630
• Other study ID #: 09-048
• Status: Terminated
• Start date: January 10, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: February 2020
• Source: Genomic Health®, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 128
• Est. completion date: February 28, 2019
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Florida Hospital Global Robotics Institute	Celebration	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Genomic Health®, Inc.	Florida Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year