Prostate Cancer Clinical Trial
Official title:
A Prospective Multi-center Observational Trial to Assess Persistence on Active Surveillance When Using the OncotypeDX® Prostate Cancer Assay
NCT number | NCT03502213 |
Other study ID # | 09-023 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2014 |
Est. completion date | June 30, 2018 |
Verified date | April 2021 |
Source | Genomic Health®, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 489 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Clinical stage T1c/T2 - PSA = 20ng/mL - Biopsy GS = 6 with any number of cores positive, or Biopsy GS 3+4 disease with =3 positive cores or = 33% positive cores - The patient must be = 50 years of age - The patient must have a life expectancy of > 10 years - Patient must be able to give consent in English or Spanish Exclusion Criteria: - Clinical stage T3a or above - PSA > 20ng/mL - Biopsy GS 4+3 or > 8 - Known metastatic prostate cancer - Positive biopsy for prostate cancer > 3 months ago - Treatment decision has already been made - Insufficient tumor in prostate biopsy tissue to perform the assay - Treatment with androgen deprivation therapy (ADT) prior to prostate biopsy - Diagnosis made by transurethral resection of prostate (TURP) shavings - Any psychiatric or psychological conditions - Contraindications to primary treatment according to physician's judgment |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Genomic Health®, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
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