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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.

Tracking Information
First Submitted Date February 19, 2016
First Posted Date May 15, 2017
Last Update Posted Date August 15, 2019
Actual Study Start Date September 1, 2015
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2017)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03152448 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 10, 2017)
  • 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
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Prospective Prolaris Value and Efficacy
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
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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
Formalin-fixed paraffin-embedded (FFPE) tissue from blocks or slides of prostatic adenocarcinoma biopsies
Sampling Method Non-Probability Sample
Study Population Newly diagnosed, clinically localized treatment naïve prostate cancer patients in the US clinical setting
Condition Prostate Cancer
Intervention 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
Study Groups/Cohorts Early Stage Prostate Cancer
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer
Intervention: Behavioral: Prolaris
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 14, 2019)
1509
Original Estimated Enrollment
 (submitted: May 10, 2017)
1500
Estimated Study Completion Date January 2024
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03152448
Other Study ID Numbers URO-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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)
Responsible Party Myriad Genetic Laboratories, Inc.
Study Sponsor Myriad Genetic Laboratories, Inc.
Collaborators VA Salt Lake City Health Care System
Investigators Not Provided
PRS Account Myriad Genetic Laboratories, Inc.
Verification Date August 2019