Study In Urology Practices Looking At Impact Of OncotypeDX GPS Test On Men Choosing And Remaining On Active Surveillance

• ClinicalTrials.gov Identifier: NCT03502213
• Recruitment Status: Completed
• First Posted: April 18, 2018
• Last Update Posted: April 23, 2021
• Sponsor: Genomic Health®, Inc.
• Information provided by (Responsible Party): Genomic Health®, Inc.

Study Description

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.

Condition or disease
Prostate Cancer

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 489 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Prospective Multi-center Observational Trial to Assess Persistence on Active Surveillance When Using the OncotypeDX® Prostate Cancer Assay
• Actual Study Start Date: July 1, 2014
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: June 30, 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Rate of persistence on Active Surveillance at 1 and 2 years after receiving the OncotypeDX Genomic Prostate Score (GPS) [ Time Frame: The analysis will estimate the absolute magnitude of the rates of persistence at these two time points (1 and 2 years after receiving 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.

Biospecimen Retention:   Samples With DNA

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].

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed with prostate cancer within the last 3 months, with no treatment decision having been made.

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

Contacts and Locations

No Contacts or Locations Provided

  Study Documents (Full-Text)

Documents provided by Genomic Health®, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] April 24, 2014

More Information

• Responsible Party: Genomic Health®, Inc.
• ClinicalTrials.gov Identifier: NCT03502213
• Other Study ID Numbers: 09-023
• First Posted: April 18, 2018
• Last Update Posted: April 23, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Genomic Health®, Inc.:

Prostate Cancer; Localized Prostate Cancer; Low Risk Prostate Cancer; Active Surveillance; Active Monitoring; OncotypeDX GPS; Genomic Prostate Score; Genomic Test; Molecular Test

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases