A Prospective Multi-center Observational Trial to Assess Persistence on Active Surveillance When Using the OncotypeDX® Prostate Cancer Assay
Sponsor study identifier
observational
489
0 countries
N/A
Study Start
July 1, 2014
Actual (reported)Primary Completion
June 30, 2018
Actual (reported)Study Completion
June 30, 2018
Actual (reported)Genomic Health's OncotypeDX® Prostate Cancer Assay is a commercially available laboratory test that measures the activity of certain genes in prostate cancer. The purpose of this study is to better understand how the use of this test result impacts or affects treatment decisions for men newly diagnosed with low risk prostate cancer, their confidence in the treatment decision, and the effects and side effects of the treatment chosen on certain aspects of Quality of Life. This study will also determine what percentage of men choosing an active monitoring program as prescribed by their doctor remain on Active Surveillance and have avoided any treatment at one year after diagnosis after receiving the assay result.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2014
Actual (reported)March 5, 2018
Actual (reported)April 18, 2018
Actual (reported)June 30, 2018
Actual (reported)June 30, 2018
Actual (reported)Rate of persistence on Active Surveillance at 1 and 2 years after receiving the OncotypeDX Genomic Prostate Score (GPS)
The analysis will estimate the absolute magnitude of the rates of persistence at these two time points, and the change between the two rates. The rate of persistence, at the particular timepoint, will be calculated as the proportion of patients who remain on Active Surveillance as of the doctor visit at the time. The rate of persistence will range from 0% to 100%, with 100% indicating all evaluable patients stay on Active Surveillance at the particular timepoint, and 0% indicating no evaluable patient on Active Surveillance.
The analysis will estimate the absolute magnitude of the rates of persistence at these two time points (1 and 2 years after receiving GPS)
Newly diagnosed with prostate cancer within the last 3 months, with no treatment decision having been made.
fixed paraffin embedded tissue (FFPE) blocks \[retained up to 2 years\], FFPE sectioned slides \[retained up to 2 years\], unstained slides \[retained up to 2 years\], and/or RNA \[retained up to 20 years\].
489 participants (actual enrollment reported by the registry).
First Submitted
March 5, 2018
First Posted
April 18, 2018
Study Start
July 1, 2014
Actual (reported)Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2018
Actual (reported)Study Completion
June 30, 2018
Actual (reported)Last Updated
April 23, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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