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

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ClinicalTrials.gov Identifier: NCT03256630
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : July 27, 2018
Sponsor:
Collaborator:
Florida Hospital
Information provided by (Responsible Party):
Genomic Health®, Inc.

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

Condition or disease
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 Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Laboratory Study To Evaluate A Blood Biomarker That Can Distinguish Between the Presence Or Absence of Aggressive Prostate Cancer
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. 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 ]

Biospecimen Description:
Blood, Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prostate cancer patients who are planning to have a Radical Prostatectomy at the Global Robotics Institute and are informed and willing to participate in study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256630


Contacts
Contact: Gaby Caceres 650-569-2132 Gcaceres@genomichealth.com

Locations
United States, Florida
Florida Hospital Global Robotics Institute Recruiting
Celebration, Florida, United States, 34747
Contact: Tadzia Harvey         
Sponsors and Collaborators
Genomic Health®, Inc.
Florida Hospital

Responsible Party: Genomic Health®, Inc.
ClinicalTrials.gov Identifier: NCT03256630     History of Changes
Other Study ID Numbers: 09-048
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Genomic Health®, Inc.:
Active Surveillance
Radical Prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases