Clinical trial NCT03502213: Study In Urology Practices Looking At Impact Of OncotypeDX GPS Test On Men Choosing And Remaining On Active Surveillance
Official title: A Prospective Multi-center Observational Trial to Assess Persistence on Active Surveillance When Using the OncotypeDX® Prostate Cancer Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Localized Prostate Cancer
Low Risk Prostate Cancer
Active Surveillance
Active Monitoring
OncotypeDX GPS
Genomic Prostate Score
Genomic Test
Molecular Test
Lead sponsor: Genomic Health®, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 489
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed with prostate cancer within the last 3 months, with no treatment decision having been made.

Brief summary: 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.

Detailed description: This is a multicenter observational study that evaluates eligible patients who will submit prostate cancer diagnostic biopsy tissues for Oncotype DX Prostate Cancer Assay testing. A physician treatment recommendation will be made and the assay is ordered. The physician will review clinical data, the GPS report and discuss treatment options with the patient. At the following visit, a shared physician-patient treatment decision (immediate treatment or AS) will be made.

Men selecting AS as primary treatment will be followed to assess persistence on AS.

There is no required or standardized AS protocol for this study and the intensity of surveillance will be at the discretion of the investigator. Patients will not be required, but may undergo a standard TRUS guided surveillance biopsy at one year. In this study, the Oncotype DX Prostate Cancer Assay will be assessed on the diagnostic biopsy only and will not be assessed on subsequent biopsies.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of persistence on Active Surveillance at 1 and 2 years after receiving the OncotypeDX Genomic Prostate Score (GPS)
timeFrame: The analysis will estimate the absolute magnitude of the rates of persistence at these two time points (1 and 2 years after receiving GPS)
Secondary outcomes:
Other outcomes:
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