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

Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Patients With Favorable Intermediate-Risk Localized Prostate Cancer Following Cell Cycle Progression (CCP) Testing (Prolaris® Test)

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: Prolaris Testing

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.

• Study Type: Observational
• Enrollment (Actual): 524

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Urology Centers of Alabama
  • Arizona
    • Mesa, Arizona, United States, 85206
      • East Valley Urology Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology
  • California
    • Concord, California, United States, 94520
      • Pacific Urology
    • Long Beach, California, United States, 90822
      • VA Long Beach Healthcare
    • Orange, California, United States, 92866
      • UCI Medical Center
    • San Jose, California, United States, 95124
      • Ssg Md Apc
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Advanced Urology Institute
    • Delray Beach, Florida, United States, 33484
      • Urology Group of Florida
    • Saint Petersburg, Florida, United States, 33710
      • Pinellas Urology
    • Sunrise, Florida, United States, 33351
      • 21st Century Oncology
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Meridian Clinical Research
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • North Idaho Urology
  • Illinois
    • Westchester, Illinois, United States, 60154
      • URO Partners
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Wichita Urology
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan, Department of Urologic Oncology
    • Royal Oak, Michigan, United States, 48073
      • Comprehensive Urology
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • UroLogic
  • New Jersey
    • Cranford, New Jersey, United States, 07016
      • Premier Urology Group, LLC
    • Cranford, New Jersey, United States, 07016
      • Premier Urology
    • Englewood, New Jersey, United States, 07631
      • Urologic Research and Consulting LLC
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University
    • Syracuse, New York, United States, 13210
      • A.M.P. Radiation Oncology
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologists of North Carolina
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • West Columbia, South Carolina, United States, 29163
      • Carolina Urology Partners
  • Tennessee
    • Nashville, Tennessee, United States, 37209
      • Urology Associates
  • Texas
    • El Paso, Texas, United States, 79912
      • Rio Grande Urology
  • Washington
    • Burien, Washington, United States, 98166
      • Seattle Urology Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed (≤ 6 months), treatment-naïve patients with favorable intermediate-risk localized prostate cancer whose initial treatment has not been decided and who are being seen at Medicare Certification and Training Registry (CTR) practices in the United States.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prolaris Testing; Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing	Diagnostic test: Prolaris Testing; Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing; Other Names: RNA expression signature of cell cycle progression genes
No Prolaris Testing; Patients with newly diagnosed favorable intermediate-risk localized prostate cancer who DO NOT undergo Prolaris testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Prolaris Score, on Active Surveillance	Proportion of patients with low Prolaris scores who are initially treated with active surveillance	3 years
Low Prolaris Score, Definitive Treatment Following Active Surveillance	Proportion of patients with low Prolaris scores and initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up	3 years
Low Prolaris Score, Disease Progression Following Delayed Definitive Treatment	Proportion of patients with low Prolaris scores and initially treated with active surveillance and later proceed to definitive treatment who develop disease progression at 5 years subsequent to the start of definitive treatment.	8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Prolaris Score, Time to Definitive Treatment following Active Surveillance	Time to definitive treatment in patients with low Prolaris scores who are initially treated with active surveillance.	8 years
No Prolaris Score, on Active Surveillance	Proportion of patients without Prolaris testing who are initially treated with active surveillance.	3 years
No Prolaris Score, Definitive Treatment Following Active Surveillance	Proportion of patients without Prolaris testing initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up.	3 years
No Prolaris Score, Time to Definitive Treatment Following Active Surveillance	Time to definitive treatment in patients without Prolaris testing who are initially treated with Active Surveillance.	8 years
No Prolaris Score, Disease Progression Following Delayed Definitive Treatment	Proportion of patients without Prolaris testing and initially treated with active surveillance who proceed with definitive treatment that develop disease progression at 5 years subsequent to the start of definitive treatment.	8 years

Collaborators and Investigators

• Sponsor: Myriad Genetic Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Prostate Cancer; Prolaris; Cell Cycle Progression Test
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: URO-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Results of Prolaris testing to be shared with patient and patient's provider. Individual participant data will be shared with investigators. Aggregate clinical date will be presented in manuscript form.
• IPD Sharing Time Frame: Within 1 year of last study out.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No