Study Stopped
Myriad has sufficient data to do an analysis on the primary objective, durability, and has made the decision not to continue collecting data for the other study objectives.
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
1 other identifier
observational
1,511
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 19, 2016
CompletedFirst Posted
Study publicly available on registry
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2022
CompletedJune 13, 2022
June 1, 2022
6.6 years
February 19, 2016
June 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Prolaris prediction of who benefits from the addition of hormone therapy to contemporary radiation therapy
5 years
Comparison of prognostic utility of prospective Prolaris testing of prostate biopsy samples to other clinical pathological parameters with respect to disease progression
5 years
Association of Prolaris score with progression to active intervention when initially managed with AS or WW
5 years
- +3 more other outcomes
Study Arms (1)
Early Stage Prostate Cancer
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer
Interventions
Series of three questionnaires to capture treatment decisions based upon standard clinical-pathological information with the addition of Prolaris genomic testing result
Eligibility Criteria
Newly diagnosed, clinically localized treatment naïve prostate cancer patients in the US clinical setting
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
VA San Diego Healthcare System
San Diego, California, 92161, United States
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
James A. Haley Veterans' Hospital
Tampa, Florida, 33612, United States
Kansas City VAMC
Kansas City, Kansas, 64128, United States
Southeast Louisiana Veterans Healtchare System
New Orleans, Louisiana, 70112, United States
Minneapolis VA Healthcare System
Minneapolis, Minnesota, 55417, United States
VA St. Louis Healthcare System
St Louis, Missouri, 63106, United States
James J. Peters VA
The Bronx, New York, 10468, United States
Oklahoma City Veteran's Hospital
Oklahoma City, Oklahoma, 73104, United States
Ralph H. Johnson VAMC
Charleston, South Carolina, 29401, United States
Michael E. DeBakey VAMC
Houston, Texas, 77030, United States
Salt Lake City VA Medical Center
Salt Lake City, Utah, 84148, United States
Biospecimen
Formalin-fixed paraffin-embedded (FFPE) tissue from blocks or slides of prostatic adenocarcinoma biopsies
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2016
First Posted
May 15, 2017
Study Start
September 1, 2015
Primary Completion
March 21, 2022
Study Completion
March 21, 2022
Last Updated
June 13, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
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)