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

NCT03502213 | Completed

• 1 other identifier: 09-023
• Study Type: observational
• Target: 489
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genomic Health®, Inc.: lead

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 \[retained up to 20 years\].

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: April 18, 2018
• Study Start: July 1, 2014
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share