Engaging Newly Diagnosed Men About Cancer Treatment Options

NCT ID: NCT02668276

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-08-31

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.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard NCCN counseling

National Comprehensive Cancer Network (NCCN) counseling uses recommendations based on currently-accepted approaches to cancer treatment.

Group Type: PLACEBO_COMPARATOR

Standard NCCN counseling

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Standard NCCN counseling and Oncotype DX results

Intervention Type: OTHER

Interventions

Standard NCCN counseling

Intervention Type: OTHER

Standard NCCN counseling and Oncotype DX results

Intervention Type: OTHER

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

• Maximum Eligible Age: 76 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Cook County Hospital

OTHER

Sponsor Role: collaborator

Genomic Health®, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Peter Gann

Professor of Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter H Gann, MD, ScD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Adam B Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Jesse Brown V. A. Medical Center

Chicago, Illinois, United States

John H. Stroger Hospital of Cook County

Chicago, Illinois, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33835822 (View on PubMed)

Other Identifiers

W81XWH-14-PCRP-BDA

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2015-1294

Identifier Type: -

Identifier Source: org_study_id