Registry to Measure the Impact of Adding Genomic Testing

NCT02454595 | Terminated

• 1 other identifier: URO-006
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The impact of genomic test results towards selecting a first-line therapy option for newly diagnosed, localized, prostate cancer patients.

  Three months

Interventions

Registry BEHAVIORAL

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).

Also known as: Prolaris

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed ( ≤ 6 months), untreated patients with histologically proven adenocarcinoma of the prostate

You may qualify if:

• 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.

You may not qualify if:

• \- Known history of hypogonadism

Sponsors & Collaborators

• Myriad Genetic Laboratories, Inc.: lead
• Intermountain Health Care, Inc.: collaborator

Study Sites (1)

Intermountain Healthcare

Salt Lake City, Utah, 84107, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed paraffin-embedded (FFPE) tissue from blocks or slides of prostatic adenocarcinoma biopsies.

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Registries

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Richard Wenstrup, MD

  Myriad Genetic Laboratories, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 27, 2015
• Study Start: November 1, 2014
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: September 5, 2017

Record last verified: 2017-07

Locations

US (1)