NCT02668276

Engaging Newly Diagnosed Men About Cancer Treatment Options

The Impact of a Gene Expression Profile on Treatment Choice and Outcome Among Minority Men Newly Diagnosed With Prostate Cancer: A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: Male
• Age: 76 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to better understand how a new lab test called the Oncotype DX Prostate Cancer Assay may impact what treatment men decide to get and how they feel and think about their choice of treatment. The study will compare men who receive this new lab test with men who receive the usual counseling given to men after they get a new diagnosis of prostate cancer. Prostate cancer is sometimes slow-growing and sometimes fast-growing. Healthcare providers are searching for better ways to predict how each tumor will behave so that each man can make a better decision about when to receive treatment. The Oncotype DX lab test uses leftover prostate biopsy tissue to generate a Genomic Prostate Score (GPS). The GPS is related to the risk of a fast-growing cancer being discovered if surgery is performed to remove a man's prostate. The goal of this study is to find out if this test helps men when they are deciding how their prostate cancer will be treated. Treatment options include surgery to remove the prostate, radiation therapy, or an approach called "active surveillance" in which there is no immediate therapy and the tumor is watched using prostate specific antigen (PSA) tests and repeat biopsies.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
OTHER	Standard NCCN counseling
OTHER	Standard NCCN counseling and Oncotype DX results

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2016-01-29
• Last updated: 2020-10-05

Locations

3 sites across 1 country: United States