ClinicalTrials.gov
ClinicalTrials.gov Menu

Registry to Measure the Impact of Adding Genomic Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02454595
Recruitment Status : Terminated (lack of enrollment)
First Posted : May 27, 2015
Last Update Posted : September 5, 2017
Sponsor:
Collaborator:
Intermountain Health Care, Inc.
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

Brief Summary:
This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. Physicians will complete a series of questionnaires. Biopsy tissue will be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician and the patient.

Condition or disease Intervention/treatment
Prostate Cancer Behavioral: Registry

Detailed Description:
This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer . Physicians, using standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores), will complete a questionnaire that will record their recommendation for first-line therapy from among various treatment options. A sample of the biopsy tissue will then be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician. After reviewing and considering the results of the genomic testing but prior to the patient consult, the physician will then complete a second treatment decision questionnaire and VAS again. The physician will then discuss the recommended treatment plan with the patient and record the agreed treatment plan on a third questionnaire. After the initial treatment has been initiated, the physician or research staff will record the actual treatment administered in the fourth questionnaire (preferably recorded within 3 months of the patient consultation).

Study Type : Observational [Patient Registry]
Actual Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients at Intermountain Hospitals
Study Start Date : November 2014
Actual Primary Completion Date : July 3, 2017
Actual Study Completion Date : July 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources


Intervention Details:
    Behavioral: Registry
    Physician will complete a series of four questionnaires to capture the treatment decisions based upon standard clinical-pathological information and with the addition of the result of genomic testing (Prolaris test).
    Other Name: Prolaris


Primary Outcome Measures :
  1. The impact of genomic test results towards selecting a first-line therapy option for newly diagnosed, localized, prostate cancer patients. [ Time Frame: Three months ]

Biospecimen Retention:   Samples With DNA
Formalin-fixed paraffin-embedded (FFPE) tissue from blocks or slides of prostatic adenocarcinoma biopsies.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed ( ≤ 6 months), untreated patients with histologically proven adenocarcinoma of the prostate
Criteria

Inclusion Criteria:

  • Newly diagnosed (< or equal to 12 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics:
  • PSA less than or equal to 10 ng/dl and
  • Gleason's 7 (4+3 or 3+4) or Gleason's 6 and
  • Age greater than 55 years old and
  • Clinical Stage T1 or T2
  • Clinically localized (no evidence on clinical or imaging studies of advanced disease).
  • No hormonal therapy including luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.

Exclusion Criteria:

- Known history of hypogonadism


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): NCT02454595


Locations
United States, Utah
Intermountain Healthcare
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Myriad Genetic Laboratories, Inc.
Intermountain Health Care, Inc.
Investigators
Study Director: Richard Wenstrup, MD Myriad Genetic Laboratories, Inc.

Responsible Party: Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT02454595     History of Changes
Other Study ID Numbers: URO-006
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: July 2017

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