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OpenTrials
Completed

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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Key information

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

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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

Other

Standard NCCN counseling and Oncotype DX results

Other

Primary outcomes

  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

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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