An observational study in Prostate Cancer, sponsored by GenomeDx Biosciences Corp. Completed at 1 site in United States. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-25.
Sponsored by GenomeDx Biosciences Corp · Observational
This clinical utility study pilot is based on a review of real but de-identified and randomized patient cases and aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test. This is a pilot study and the primary intent is to help guide development and design of future clinical utility studies for Decipher
The primary and secondary objectives will be assessed in retrospectively selected prostate cancer patients treated with radical prostatectomy with one or more adverse pathological features (APFs)
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 21 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →GenomeDx Biosciences Corp is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. The study participants are the urologists who review the selected case files.
Criteria (Participant enrollment)
Inclusion Criteria Study participants:
Exclusion Criteria Study Participants:
(1) Did not meet the inclusion criteria
Criteria (Case selection)
Inclusion Criteria Case File:
Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse pathological features present defined as:
Pathological Gleason score >= 8 or Gleason score 7 with primary pattern 4; Pathological stage T3A (= Extraprostatic extension) or T3B (=Seminal vesicle invasion); Positive surgical margins Gleason grade upgrade from biopsy to surgery
Exclusion Criteria Case File:
Metastatic disease (M+) prior to surgery Received any neo-adjuvant prostate cancer treatment with radical prostatectomy (radiation, hormone, chemotherapy)
Performing at least 60 radical prostate surgeries annually
Other: DECIPHER Questionnaire
Participants are asked to complete a questionnaire to assess the impact of Decipher on physicians' treatment recommendation. All participants use the same data collection instrument. Each participant opinion is collected based on a random selection of cases.
Change in treatment recommendation
To determine the extent to which the use of the Decipher test influences treatment recommendations by physicians post radical prostatectomy (RP). This decision impact study aims to evaluate Urologists' treatment recommendations before and after reviewing the results provided by the Decipher test.
Time frame: 1.5 years
Urologist's perception regarding the utility of the Decipher
* Changes in Urologists expressed level of confidence in the treatment recommendation as measured by the response to item 4a in the eCRF survey. * Urologist's perception regarding the utility of the Decipher test as measured by the responses to question 4b and 38b and 38c in the eCRF survey. * Agreement in treatment recommendation
Time frame: 1.5 years
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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