Clinical trial NCT02668276: Engaging Newly Diagnosed Men About Cancer Treatment Options
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: Prostatic neoplasms
Oncotype DX
Treatment Decisions
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Cook County Hospital
name: Genomic Health®, Inc.
First posted: 2016-01-29
Enrollment: 200
Sex: MALE
Maximum age (years): 76
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Effect of adding Oncotype DX prostate cancer assay to usual counseling on the proportion of men adopting Active Surveillance (AS).
timeFrame: 3-6 months after treatment decision
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown V. A. Medical Center
state: Illinois
city: Chicago
country: United States
facility: John H. Stroger Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Peter H Gann, MD, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Adam B Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.