Engaging Newly Diagnosed Men About Cancer Treatment Options

Not Applicable

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Other: Standard NCCN counseling and Oncotype DX results; Other: Standard NCCN counseling

• Registration Number: NCT02668276
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Study Start: 2016-04
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard NCCN counseling and Oncotype DX results	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.
Standard NCCN counseling	Standard NCCN counseling	National Comprehensive Cancer Network (NCCN) counseling uses recommendations based on currently-accepted approaches to cancer treatment.

Primary Outcome Measures

Name	Time	Method
Effect of adding Oncotype DX prostate cancer assay to usual counseling on the proportion of men adopting Active Surveillance (AS).	3-6 months after treatment decision

Trial Locations

Locations (3)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Jesse Brown V. A. Medical Center; 🇺🇸 Chicago, Illinois, United States

John H. Stroger Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States