Registry to Measure the Impact of Adding Genomic Testing

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02454595
• Other study ID #: URO-006
• Status: Terminated
• Phase: N/A
• First received: May 4, 2015
• Last updated: August 31, 2017
• Start date: November 2014
• Est. completion date: July 3, 2017

Study information

• Verified date: July 2017
• Source: Myriad Genetic Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 116
• Est. completion date: July 3, 2017
• Est. primary completion date: July 3, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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).

Locations

Country	Name	City	State
United States	Intermountain Healthcare	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Myriad Genetic Laboratories, Inc.	Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The impact of genomic test results towards selecting a first-line therapy option for newly diagnosed, localized, prostate cancer patients.		Three months