Engaging Newly Diagnosed Men About Cancer Treatment Options (ENACT)

University of Illinois

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Other: Standard NCCN counseling; Other: Standard NCCN counseling and Oncotype DX results

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT02668276

W81XWH-14-PCRP-BDA (Other Grant/Funding Number)

2015-1294

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Male

Ages: Under 76 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups, including a placebo group

Standard NCCN counseling

Placebo Comparator group

Description:

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

Treatment:

Other: Standard NCCN counseling

Standard NCCN counseling and Oncotype DX results

Experimental group

Description:

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.

Treatment:

Other: Standard NCCN counseling and Oncotype DX results