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Prospective Prolaris Value and Efficacy (P-PROVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03152448
Recruitment Status : Active, not recruiting
First Posted : May 15, 2017
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
VA Salt Lake City Health Care System
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

Brief Summary:
This is a prospective study to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer.

Condition or disease Intervention/treatment
Prostate Cancer Behavioral: Prolaris

Detailed Description:

This is a prospective study to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. Multiple individual VAMC sites will participate in PART 1 of the study. During PART 1 of the study, a three-part questionnaire will be completed to evaluate the PRE-Prolaris test treatment plan, the POST-Prolaris test treatment plan, and the ACTUAL treatment option. Using PRE-Prolaris Test Questionnaire #1 the physician will record the recommendation for first-line therapy based on standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores). The likelihood of recommending a non-interventional therapy approach will also be recorded using a 10-point ordinal scale. A sample of the biopsy tissue will then be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician. After reviewing and considering the results of the genomic testing and after patient consultation, the physician will complete POST-Prolaris Questionnaire #2 documenting the planned treatment ( interventional treatment or non-interventional). Approximately 6 months from the date of the test results, ACTUAL Treatment Questionnaire #3 will be completed to document the actual treatment administered.

PART 2 of this study is a prospective evaluation of the prognostic utility of Prolaris® testing of prostate biopsy samples obtained from men who participate in PART 1of the study and who undergo radical prostatectomy or radiation therapy or who are managed with WW or AS. The central VAMC site will be responsible for PART 2; individual VAMC sites will not participate in this part of the study. Patients will be followed using medical record review every 6 months for objective progression (BCR, radiographic or radionuclide evidence of metastases or disease specific mortality) through 5 years.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 1509 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Two-Part Prospective Study to Measure Impact of Prolaris® Testing Added to Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients to Measure Prediction of Progression/Recurrence in Men Treated at VAMC
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Early Stage Prostate Cancer
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer
Behavioral: Prolaris
Series of three questionnaires to capture treatment decisions based upon standard clinical-pathological information with the addition of Prolaris genomic testing result
Other Name: RNA expression signature based on a set of cell cycle progression (CCP) genes




Primary Outcome Measures :
  1. Impact of Prolaris on magnitude of change between pre-Prolaris treatment selection and the post-Prolaris treatment plan following consultation with the patient [ Time Frame: 3 months ]
    comparison of percentage change from the pre-Prolaris treatment option versus the post-Prolaris treatment plan

  2. Impact of Prolaris on magnitude of change between physician likelihood of recommending non-interventional therapy and the likelihood following the genomic test results [ Time Frame: 3 months ]
    mean change in the physician's likelihood of recommending watchful waiting or active surveillance post-genomic testing compared to pre-genomic testing


Other Outcome Measures:
  1. Prolaris prediction of who benefits from the addition of hormone therapy to contemporary radiation therapy [ Time Frame: 5 years ]
    either biochemical or objective recurrences of disease following definitive therapy with curative intent in men treated with radiation who did or did not receive adjuvant ADT

  2. Comparison of prognostic utility of prospective Prolaris testing of prostate biopsy samples to other clinical pathological parameters with respect to disease progression [ Time Frame: 5 years ]
    either biochemical or objective recurrences of disease following definitive therapy with curative intent in men treated with radical prostatectomy or radiation

  3. Association of Prolaris score with progression to active intervention when initially managed with AS or WW [ Time Frame: 5 years ]
    Progression to interventional therapy in men initially managed with AS or WW

  4. Prognostic utility of Prolaris testing compared to other clinical pathological parameters with respect to disease progression in men who were Gleason score <7 on initial biopsy [ Time Frame: 5 years ]
    biochemical or objective recurrence of disease in men who were Gleason score <7


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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed, clinically localized treatment naïve prostate cancer patients in the US clinical setting
Criteria

Inclusion Criteria:

  • Newly diagnosed (<= 6 months), untreated patients with histologically proven adenocarcinoma of the prostate
  • Final treatment decision has not been made (that is all treatment options are feasible and none have been ruled out due to comorbidities at study entry)
  • Clinically localized (no evidence on clinical or imaging studies of advanced disease)
  • No hormonal therapy for treatment of prostate cancer including LHRH agonist or antagonist, anti-androgen, estrogens or exogenous androgens when applicable (use of 5-alpha reductase inhibitors is acceptable)
  • Sufficient amount of tissue remains from biopsy to perform genomic testing
  • Life expectance of a minimum of 10 years
  • Men who completed PART 1 and were treated with radical prostatectomy (including robotic, laparoscopic, open retropubic or perineal) or receive radiation therapy or were placed on AS or WW.

Exclusion Criteria:

  • Men with clinical node positive or metastatic disease
  • Men with a known baseline total serum testosterone level of <100 ng/dL prior to radiation or hormone therapy (men with unknown baseline testosterone levels will not be excluded)
  • Men who previously received pelvic radiotherapy for another malignancy
  • Non adenocarcinoma prostate cancer histologies

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): NCT03152448


Locations
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United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
United States, Florida
James A. Haley Veterans' Hospital
Tampa, Florida, United States, 33612
United States, Kansas
Kansas City VAMC
Kansas City, Kansas, United States, 64128
United States, Louisiana
Southeast Louisiana Veterans Healtchare System
New Orleans, Louisiana, United States, 70112
United States, Minnesota
Minneapolis VA Healthcare System
Minneapolis, Minnesota, United States, 55417
United States, Missouri
VA St. Louis Healthcare System
Saint Louis, Missouri, United States, 63106
United States, New York
James J. Peters VA
Bronx, New York, United States, 10468
United States, Oklahoma
Oklahoma City Veteran's Hospital
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Ralph H. Johnson VAMC
Charleston, South Carolina, United States, 29401
United States, Texas
Michael E. DeBakey VAMC
Houston, Texas, United States, 77030
United States, Utah
Salt Lake City VA Medical Center
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
Myriad Genetic Laboratories, Inc.
VA Salt Lake City Health Care System

Additional Information:

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Responsible Party: Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT03152448     History of Changes
Other Study ID Numbers: URO-005
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results of Prolaris testing to be shared with provider and patient per commercial process; study results to be presented in a pier reviewed publication in aggregate form only (no individual participant data to be shared through publications or abstracts)

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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

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