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

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ClinicalTrials.gov Identifier: NCT03290508
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

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
Prostate Cancer 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 [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Years
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 : September 14, 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: 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



Primary Outcome Measures :
  1. Low Prolaris Score, on Active Surveillance [ Time Frame: 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 [ 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. 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.


Secondary Outcome Measures :
  1. 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.

  2. No Prolaris Score, on Active Surveillance [ Time Frame: 3 years ]
    Proportion of patients without Prolaris testing who are initially treated with active surveillance.

  3. 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.

  4. 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.

  5. 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.


Biospecimen Retention:   Samples With DNA
Formalin-fixed paraffin-embedded (FFPE) tissue from blocks or slides of prostatic adenocarcinoma biopsies


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290508


Contacts
Contact: Bryan Dechairo, PhD 801-584-1134 bryan.dechairo@myriad.com

  Show 36 Study Locations
Sponsors and Collaborators
Myriad Genetic Laboratories, Inc.

Responsible Party: Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT03290508     History of Changes
Other Study ID Numbers: URO-008
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: Within 1 year of last study out.

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.:
Prolaris
Prostate Cancer
Cell Cycle Progression Test

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases