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

NCT ID: NCT03290508

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 524 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-14
• Study Completion Date: 2022-01-14

Brief Summary

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 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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prolaris Testing

Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing

Prolaris Testing

Intervention Type: DIAGNOSTIC_TEST

Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing

No Prolaris Testing

Patients with newly diagnosed favorable intermediate-risk localized prostate cancer who DO NOT undergo Prolaris testing

No interventions assigned to this group

Interventions

Prolaris Testing

Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

RNA expression signature of cell cycle progression genes

Eligibility Criteria

Inclusion Criteria

• Patients who have undergone CCP testing and patients who have not undergone CCP testing will be considered for enrollment in the study.

1. Willing to provide written informed consent.

2. Males ≥65 years old.

3. Newly diagnosed (≤6 months), treatment-naïve patient with histologically proven localized adenocarcinoma of prostate whose initial treatment has not been decided.

4. Candidate for and considering AS and yet would be eligible for definitive therapy.

5. Favorable intermediate-risk disease, defined by the NCCN as follows:

• predominant Gleason grade 3; AND
• percentage of positive cores <50%; AND
• no more than 1 of the following NCCN intermediate-risk factors:

• Gleason grade 7
• T2b-T2c
• PSA 10-20 ng/mL

6. Estimated life expectancy ≥10 years.

7. Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).

Exclusion Criteria

• 1. Clinical evidence of metastasis or lymph node involvement.
• 2. Received pelvic radiation prior to biopsy.
• 3. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitors (5-ARIs) are permitted.
• 4. Participation in interventional clinical trials.
• 5. Patient is considering watchful waiting.
• 6. Has a known history of hypogonadism.

• Minimum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Myriad Genetic Laboratories, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Urology Centers of Alabama

Homewood, Alabama, United States

East Valley Urology Center

Mesa, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Arkansas Urology

Little Rock, Arkansas, United States

Pacific Urology

Concord, California, United States

VA Long Beach Healthcare

Long Beach, California, United States

UCI Medical Center

Orange, California, United States

Ssg Md Apc

San Jose, California, United States

Advanced Urology Institute

Daytona Beach, Florida, United States

Urology Group of Florida

Delray Beach, Florida, United States

Pinellas Urology

St. Petersburg, Florida, United States

21st Century Oncology

Sunrise, Florida, United States

Meridian Clinical Research

Savannah, Georgia, United States

North Idaho Urology

Coeur d'Alene, Idaho, United States

URO Partners

Westchester, Illinois, United States

Wichita Urology

Wichita, Kansas, United States

Regional Urology

Shreveport, Louisiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

University of Michigan, Department of Urologic Oncology

Ann Arbor, Michigan, United States

Comprehensive Urology

Royal Oak, Michigan, United States

Michigan Institute of Urology

Troy, Michigan, United States

UroLogic

Tupelo, Mississippi, United States

Premier Urology Group, LLC

Cranford, New Jersey, United States

Premier Urology

Cranford, New Jersey, United States

Urologic Research and Consulting LLC

Englewood, New Jersey, United States

Stony Brook University

Stony Brook, New York, United States

A.M.P. Radiation Oncology

Syracuse, New York, United States

Associated Urologists of North Carolina

Raleigh, North Carolina, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Carolina Urology Partners

West Columbia, South Carolina, United States

Urology Associates

Nashville, Tennessee, United States

Rio Grande Urology

El Paso, Texas, United States

Seattle Urology Research Center

Burien, Washington, United States

Countries

United States

Other Identifiers

URO-008

Identifier Type: -

Identifier Source: org_study_id