Prospective Prolaris Value and Efficacy (P-PROVE)

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

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 1511

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed, clinically localized treatment naïve prostate cancer patients in the US clinical setting

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: RNA expression signature based on a set of cell cycle progression (CCP) genes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of Prolaris on the magnitude of change between Pre-Prolaris treatment selection and the actual implemented treatment	Comparison of percentage change from the Pre-Prolaris test treatment option (based on standard clinical pathological parameters) versus the actual treatment option implemented following results of Prolaris	6 months
Prolaris prediction of biochemical or objective recurrence	Biochemical recurrence (defined as PSA >0.2 ng/ml or by Phoenix definition) or objective recurrences of disease by 5 years following definitive therapy with curative intent in men treatment with radical prostatectomy or radiation therapy	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolaris prediction of who benefits from the addition of hormone therapy to contemporary radiation therapy	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	5 years
Comparison of prognostic utility of prospective Prolaris testing of prostate biopsy samples to other clinical pathological parameters with respect to disease progression	either biochemical or objective recurrences of disease following definitive therapy with curative intent in men treated with radical prostatectomy or radiation	5 years
Association of Prolaris score with progression to active intervention when initially managed with AS or WW	Progression to interventional therapy in men initially managed with AS or WW	5 years
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	biochemical or objective recurrence of disease in men who were Gleason score <7	5 years
Impact of Prolaris on magnitude of change between pre-Prolaris treatment selection and the post-Prolaris treatment plan following consultation with the patient	comparison of percentage change from the pre-Prolaris treatment option versus the post-Prolaris treatment plan	3 months
Impact of Prolaris on magnitude of change between physician likelihood of recommending non-interventional therapy and the likelihood following the genomic test results	mean change in the physician's likelihood of recommending watchful waiting or active surveillance post-genomic testing compared to pre-genomic testing	3 months

Collaborators and Investigators

• Sponsor: Myriad Genetic Laboratories, Inc.
• Collaborators: VA Salt Lake City Health Care System

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ACTUAL): March 21, 2022
• Study Completion (ACTUAL): March 21, 2022

Study Registration Dates

• First Submitted: February 19, 2016
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (ACTUAL): May 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Prostate Cancer; Prolaris
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: URO-005

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 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)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No