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

June 17, 2022 updated by: Myriad Genetic Laboratories, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
524

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Low Prolaris Score, on Active Surveillance
Time Frame: 3 years
Proportion of patients with low Prolaris scores who are initially treated with active surveillance
3 years
Low Prolaris Score, Definitive Treatment Following Active Surveillance
Time Frame: 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 years
Low Prolaris Score, Disease Progression Following Delayed Definitive Treatment
Time Frame: 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.
8 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Low Prolaris Score, Time to Definitive Treatment following Active Surveillance
Time Frame: 8 years
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
Time Frame: 3 years
Proportion of patients without Prolaris testing who are initially treated with active surveillance.
3 years
No Prolaris Score, Definitive Treatment Following Active Surveillance
Time Frame: 3 years
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 Frame: 8 years
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
Time Frame: 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.
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Myriad Genetic Laboratories, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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