Engaging Newly Diagnosed Men About Cancer Treatment Options (ENACT)

• ClinicalTrials.gov Identifier: NCT02668276
• Recruitment Status: Completed
• First Posted: January 29, 2016
• Last Update Posted: October 5, 2020
• Sponsor: University of Illinois at Chicago
• Collaborators: United States Department of Defense; Cook County Hospital; Genomic Health®, Inc.
• Information provided by (Responsible Party): Peter Gann, University of Illinois at Chicago

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Prostatic Neoplasms	Other: Standard NCCN counseling; Other: Standard NCCN counseling and Oncotype DX results	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Study Start Date: April 2016
• Actual Primary Completion Date: August 2019
• Actual Study Completion Date: August 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Standard NCCN counseling; National Comprehensive Cancer Network (NCCN) counseling uses recommendations based on currently-accepted approaches to cancer treatment.	Other: Standard NCCN counseling
Experimental: Standard NCCN counseling and Oncotype DX results; National Comprehensive Cancer Network (NCCN) counseling uses recommendations based on currently-accepted approaches to cancer treatment. The result provided by the Oncotype DX prostate test is called a Genomic Prostate Score (GPS). The GPS provides important information about how aggressive a man's cancer is based on the biology of the man's individual tumor.	Other: Standard NCCN counseling and Oncotype DX results

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: up to 76 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Illinois

Jesse Brown V. A. Medical Center

Chicago, Illinois, United States, 60612

John H. Stroger Hospital of Cook County

Chicago, Illinois, United States, 60612

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

Sponsors and Collaborators

University of Illinois at Chicago

United States Department of Defense

Cook County Hospital

Genomic Health®, Inc.

Investigators

• Principal Investigator: Peter H Gann, MD, ScD; University of Illinois at Chicago
• Principal Investigator: Adam B Murphy, MD; Northwestern University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Murphy AB, Abern MR, Liu L, Wang H, Hollowell CMP, Sharifi R, Vidal P, Kajdacsy-Balla A, Sekosan M, Ferrer K, Wu S, Gallegos M, King-Lee P, Sharp LK, Ferrans CE, Gann PH. Impact of a Genomic Test on Treatment Decision in a Predominantly African American Population With Favorable-Risk Prostate Cancer: A Randomized Trial. J Clin Oncol. 2021 May 20;39(15):1660-1670. doi: 10.1200/JCO.20.02997. Epub 2021 Apr 9.

• Responsible Party: Peter Gann, Professor of Pathology, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT02668276
• Other Study ID Numbers: 2015-1294; W81XWH-14-PCRP-BDA ( Other Grant/Funding Number: US Department of Defense )
• First Posted: January 29, 2016
• Last Update Posted: October 5, 2020
• Last Verified: October 2020

Keywords provided by Peter Gann, University of Illinois at Chicago:

Prostatic neoplasms; Oncotype DX; Treatment Decisions

Additional relevant MeSH terms:

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