Engaging Newly Diagnosed Men About Cancer Treatment Options

Prostatic Neoplasms Clinical Trial

— ENACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668276
• Other study ID #: 2015-1294
• Secondary ID: W81XWH-14-PCRP-B
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: August 2019

Study information

• Verified date: October 2020
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Other:
• Standard NCCN counseling

• Standard NCCN counseling and Oncotype DX results

Locations

Country	Name	City	State
United States	Jesse Brown V. A. Medical Center	Chicago	Illinois
United States	John H. Stroger Hospital of Cook County	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Cook County Hospital, Genomic Health®, Inc., United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of adding Oncotype DX prostate cancer assay to usual counseling on the proportion of men adopting Active Surveillance (AS).		3-6 months after treatment decision