Last updated on May 2019

Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer


Brief description of study

This is a long-term prospective registry study to determine whether Prolaris testing in patients with favorable intermediate risk prostate cancer influences physician management decisions toward conservative treatment in patients with Prolaris low-risk scores without negatively impacting patient oncologic outcomes, thereby sparing low-risk patients from unnecessary treatments and associated side-effects.

Detailed Study Description

This is a long-term prospective registry to evaluate the impact of Prolaris testing on therapeutic decisions in patients with newly diagnosed favorable intermediate-risk localized prostate cancer and to summarize clinical oncologic outcomes. The design of the study is non-interventional, and therefore the protocol will not require a specific treatment plan for study participants. However, in the absence of a universally accepted timeframe for repeat biopsies within existing active surveillance recommendations, study sites will be encouraged to monitor patients for disease progression as per the standard of care (e.g., current National Comprehensive Cancer Network [NCCN] guidelines) with the expectation of a repeat biopsy within 18 months of the initial biopsy.

Patients who undergo Prolaris testing will be included in the registry as well as patients who do not undergo Prolaris testing. Data collection for the first primary objective extends over a 3-year period. During this time, data is collected on the treatment initiated, any follow-up prostate biopsy performed in patients initially treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.

Data collection for the second primary objective extends out to 8 years. During this time data is collected on any follow-up prostate biopsy in patients still treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.

Clinical Study Identifier: NCT03290508

Find a site near you

Start Over

VA Long Beach Healthcare

Long Beach, CA United States
  Connect »

Premier Urology

Cranford, NJ United States
  Connect »

Urology Centers of Alabama

Homewood, AL United States
  Connect »

Ssg Md Apc

San Jose, CA United States
  Connect »

Regional Urology

Shreveport, LA United States
  Connect »

Premier Urology Group, LLC

Cranford, NJ United States
  Connect »

Urology Group of Florida

Delray Beach, FL United States
  Connect »

Comprehensive Urology

Royal Oak, MI United States
  Connect »

Pacific Urology

Concord, CA United States
  Connect »

Wichita Urology

Wichita, KS United States
  Connect »

Lancaster Urology

Lancaster, PA United States
  Connect »

Meridian Clinical Research

Savannah, GA United States
  Connect »

UroLogic

Tupelo, MS United States
  Connect »

URO Partners

Westchester, IL United States
  Connect »

Lehigh Valley Health Network

Allentown, PA United States
  Connect »

Carolina Urology Partners

West Columbia, SC United States
  Connect »

Rio Grande Urology

El Paso, TX United States
  Connect »

Southwest Urology

Middleburg Heights, OH United States
  Connect »

Arkansas Urology

Little Rock, AR United States
  Connect »

UCI Medical Center

Orange, CA United States
  Connect »

Advanced Urology Institute

Daytona Beach, FL United States
  Connect »

Pinellas Urology

Saint Petersburg, FL United States
  Connect »

21st Century Oncology

Sunrise, FL United States
  Connect »

North Idaho Urology

Coeur d'Alene, ID United States
  Connect »

Premier Medical Group

Poughkeepsie, NY United States
  Connect »

Stony Brook University

Stony Brook, NY United States
  Connect »

A.M.P. Radiation Oncology

Syracuse, NY United States
  Connect »

Urology Associates

Nashville, TN United States
  Connect »

Urology of VA

Virginia Beach, VA United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.