NCT Number: NCT02668276
Engaging Newly Diagnosed Men About Cancer Treatment Options
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.
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Notify MeKey information
Conditions
Age range
Up to 76 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
Jesse Brown V. A. Medical Center, Chicago, Illinois, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Men with newly diagnosed prostate cancer who are categorized as Very Low, Low, or Intermediate risk by NCCN criteria;
- Are age 76 or younger
Exclusion criteria
- Men who are categorized as High or Very High risk by NCCN criteria;
- Men who have already received counseling from their urologist about their treatment options and have decided to undergo treatment, active surveillance, or watchful waiting;
- Men age 77 or older
Treatment and study plan
Standard NCCN counseling and Oncotype DX results
OtherPrimary outcomes
-
Effect of adding Oncotype DX prostate cancer assay to usual counseling on the proportion of men adopting Active Surveillance (AS).
Time frame: 3-6 months after treatment decision
Sponsors and collaborators
Lead sponsor
University of Illinois at Chicago
Other
Collaborators
- Cook County Hospital
- Genomic Health®, Inc.
- United States Department of Defense
Registry information
Official study title
The Impact of a Gene Expression Profile on Treatment Choice and Outcome Among Minority Men Newly Diagnosed With Prostate Cancer: A Randomized Trial
Acronym: ENACT
Important dates
- Study start
- 2016
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Jan 29, 2016
- Registry last updated
- Oct 5, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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