Engaging Newly Diagnosed Men About Cancer Treatment Options (ENACT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02668276 |
Recruitment Status :
Completed
First Posted : January 29, 2016
Last Update Posted : October 5, 2020
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Condition or disease | Intervention/treatment | Phase |
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Prostatic Neoplasms | Other: Standard NCCN counseling Other: Standard NCCN counseling and Oncotype DX results | Not Applicable |
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 |

Arm | Intervention/treatment |
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Placebo Comparator: Standard NCCN counseling
National Comprehensive Cancer Network (NCCN) counseling uses recommendations based on currently-accepted approaches to cancer treatment.
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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.
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Other: Standard NCCN counseling and Oncotype DX results |
- 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 ]

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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 |
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

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
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 |
Principal Investigator: | Peter H Gann, MD, ScD | University of Illinois at Chicago | |
Principal Investigator: | Adam B Murphy, MD | Northwestern University |
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 |
Prostatic neoplasms Oncotype DX Treatment Decisions |
Prostatic Neoplasms Neoplasms Genital Neoplasms, Male |
Urogenital Neoplasms Neoplasms by Site Prostatic Diseases |