An observational study in Prostate Cancer, sponsored by Myriad Genetic Laboratories, Inc.. Terminated at 1 site in United States. Open to male participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2017-09-05.
Sponsored by Myriad Genetic Laboratories, Inc. · Observational
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.
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).
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 116 is below the median of 200 across 1,179 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Myriad Genetic Laboratories, Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Newly diagnosed ( ≤ 6 months), untreated patients with histologically proven adenocarcinoma of the prostate
Exclusion Criteria:
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
The impact of genomic test results towards selecting a first-line therapy option for newly diagnosed, localized, prostate cancer patients.
Time frame: Three months
This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Myriad Genetic Laboratories, Inc.