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

Sponsor
Myriad Genetic Laboratories, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03290508
Collaborator
(none)
524
34
52
15.4
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
524 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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)
Actual Study Start Date :
Sep 14, 2017
Actual Primary Completion Date :
Jan 14, 2022
Actual Study Completion Date :
Jan 14, 2022

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. Low Prolaris Score, on Active Surveillance [3 years]

      Proportion of patients with low Prolaris scores who are initially treated with active surveillance

    2. Low Prolaris Score, Definitive Treatment Following Active Surveillance [3 years]

      Proportion of patients with low Prolaris scores and initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up

    3. Low Prolaris Score, Disease Progression Following Delayed Definitive Treatment [8 years]

      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.

    Secondary Outcome Measures

    1. Low Prolaris Score, Time to Definitive Treatment following Active Surveillance [8 years]

      Time to definitive treatment in patients with low Prolaris scores who are initially treated with active surveillance.

    2. No Prolaris Score, on Active Surveillance [3 years]

      Proportion of patients without Prolaris testing who are initially treated with active surveillance.

    3. No Prolaris Score, Definitive Treatment Following Active Surveillance [3 years]

      Proportion of patients without Prolaris testing initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up.

    4. No Prolaris Score, Time to Definitive Treatment Following Active Surveillance [8 years]

      Time to definitive treatment in patients without Prolaris testing who are initially treated with Active Surveillance.

    5. No Prolaris Score, Disease Progression Following Delayed Definitive Treatment [8 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    1. Estimated life expectancy ≥10 years.

    2. 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.
      1. Received pelvic radiation prior to biopsy.
      1. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitors (5-ARIs) are permitted.
      1. Participation in interventional clinical trials.
      1. Patient is considering watchful waiting.
      1. Has a known history of hypogonadism.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology Centers of Alabama Homewood Alabama United States 35209
    2 East Valley Urology Center Mesa Arizona United States 85206
    3 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    4 Arkansas Urology Little Rock Arkansas United States 72211
    5 Pacific Urology Concord California United States 94520
    6 VA Long Beach Healthcare Long Beach California United States 90822
    7 UCI Medical Center Orange California United States 92866
    8 Ssg Md Apc San Jose California United States 95124
    9 Advanced Urology Institute Daytona Beach Florida United States 32114
    10 Urology Group of Florida Delray Beach Florida United States 33484
    11 Pinellas Urology Saint Petersburg Florida United States 33710
    12 21st Century Oncology Sunrise Florida United States 33351
    13 Meridian Clinical Research Savannah Georgia United States 31405
    14 North Idaho Urology Coeur d'Alene Idaho United States 83814
    15 URO Partners Westchester Illinois United States 60154
    16 Wichita Urology Wichita Kansas United States 67226
    17 Regional Urology Shreveport Louisiana United States 71106
    18 Tufts Medical Center Boston Massachusetts United States 02111
    19 University of Michigan, Department of Urologic Oncology Ann Arbor Michigan United States 48109
    20 Comprehensive Urology Royal Oak Michigan United States 48073
    21 Michigan Institute of Urology Troy Michigan United States 48084
    22 UroLogic Tupelo Mississippi United States 38801
    23 Premier Urology Group, LLC Cranford New Jersey United States 07016
    24 Premier Urology Cranford New Jersey United States 07016
    25 Urologic Research and Consulting LLC Englewood New Jersey United States 07631
    26 Stony Brook University Stony Brook New York United States 11794
    27 A.M.P. Radiation Oncology Syracuse New York United States 13210
    28 Associated Urologists of North Carolina Raleigh North Carolina United States 27612
    29 Lehigh Valley Health Network Allentown Pennsylvania United States 18103
    30 Medical University of South Carolina Charleston South Carolina United States 29425
    31 Carolina Urology Partners West Columbia South Carolina United States 29163
    32 Urology Associates Nashville Tennessee United States 37209
    33 Rio Grande Urology El Paso Texas United States 79912
    34 Seattle Urology Research Center Burien Washington United States 98166

    Sponsors and Collaborators

    • Myriad Genetic Laboratories, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Myriad Genetic Laboratories, Inc.
    ClinicalTrials.gov Identifier:
    NCT03290508
    Other Study ID Numbers:
    • URO-008
    First Posted:
    Sep 25, 2017
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Myriad Genetic Laboratories, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 23, 2022