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

NCT ID: NCT03502213

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 489 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-01
• Study Completion Date: 2018-06-30

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Genomic Health®, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

09-023

Identifier Type: -

Identifier Source: org_study_id