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Engaging Newly Diagnosed Men About Cancer Treatment Options (ENACT)

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668276


Locations
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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
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Principal Investigator: Peter H Gann, MD, ScD University of Illinois at Chicago
Principal Investigator: Adam B Murphy, MD Northwestern University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
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:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases