Clinical trial NCT02454595: Registry to Measure the Impact of Adding Genomic Testing
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Intermountain Health Care, Inc.
First posted: 2015-05-27
Enrollment: 116
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed ( ≤ 6 months), untreated patients with histologically proven adenocarcinoma of the prostate

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.

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).

Eligibility 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

Primary outcomes:
measure: The impact of genomic test results towards selecting a first-line therapy option for newly diagnosed, localized, prostate cancer patients.
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Intermountain Healthcare
state: Utah
Study officials:
affiliation: Myriad Genetic Laboratories, Inc.
name: Richard Wenstrup, MD
role: STUDY_DIRECTOR
References: