Study Stopped
There is sufficient follow-up data to meet the endpoints of the study.
Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer
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)
1 other identifier
observational
524
1 country
34
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.
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 2017
Longer than P75 for all trials
34 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 14, 2017
CompletedFirst Submitted
Initial submission to the registry
September 19, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2022
CompletedJune 23, 2022
June 1, 2022
4.3 years
September 19, 2017
June 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Low Prolaris Score, on Active Surveillance
Proportion of patients with low Prolaris scores who are initially treated with active surveillance
3 years
Low Prolaris Score, Definitive Treatment Following Active Surveillance
Proportion of patients with low Prolaris scores and initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up
3 years
Low Prolaris Score, Disease Progression Following Delayed Definitive Treatment
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.
8 years
Secondary Outcomes (5)
Low Prolaris Score, Time to Definitive Treatment following Active Surveillance
8 years
No Prolaris Score, on Active Surveillance
3 years
No Prolaris Score, Definitive Treatment Following Active Surveillance
3 years
No Prolaris Score, Time to Definitive Treatment Following Active Surveillance
8 years
No Prolaris Score, Disease Progression Following Delayed Definitive Treatment
8 years
Study Arms (2)
Prolaris Testing
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing
No Prolaris Testing
Patients with newly diagnosed favorable intermediate-risk localized prostate cancer who DO NOT undergo Prolaris testing
Interventions
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing
Eligibility Criteria
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.
You may qualify if:
- Patients who have undergone CCP testing and patients who have not undergone CCP testing will be considered for enrollment in the study.
- Willing to provide written informed consent.
- Males ≥65 years old.
- Newly diagnosed (≤6 months), treatment-naïve patient with histologically proven localized adenocarcinoma of prostate whose initial treatment has not been decided.
- Candidate for and considering AS and yet would be eligible for definitive therapy.
- 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
- Estimated life expectancy ≥10 years.
- Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).
You may not qualify if:
- \. Clinical evidence of metastasis or lymph node involvement.
- \. Received pelvic radiation prior to biopsy.
- \. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitors (5-ARIs) are permitted.
- \. Participation in interventional clinical trials.
- \. Patient is considering watchful waiting.
- \. Has a known history of hypogonadism.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
East Valley Urology Center
Mesa, Arizona, 85206, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Arkansas Urology
Little Rock, Arkansas, 72211, United States
Pacific Urology
Concord, California, 94520, United States
VA Long Beach Healthcare
Long Beach, California, 90822, United States
UCI Medical Center
Orange, California, 92866, United States
Ssg Md Apc
San Jose, California, 95124, United States
Advanced Urology Institute
Daytona Beach, Florida, 32114, United States
Urology Group of Florida
Delray Beach, Florida, 33484, United States
Pinellas Urology
St. Petersburg, Florida, 33710, United States
21st Century Oncology
Sunrise, Florida, 33351, United States
Meridian Clinical Research
Savannah, Georgia, 31405, United States
North Idaho Urology
Coeur d'Alene, Idaho, 83814, United States
URO Partners
Westchester, Illinois, 60154, United States
Wichita Urology
Wichita, Kansas, 67226, United States
Regional Urology
Shreveport, Louisiana, 71106, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Michigan, Department of Urologic Oncology
Ann Arbor, Michigan, 48109, United States
Comprehensive Urology
Royal Oak, Michigan, 48073, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
UroLogic
Tupelo, Mississippi, 38801, United States
Premier Urology Group, LLC
Cranford, New Jersey, 07016, United States
Premier Urology
Cranford, New Jersey, 07016, United States
Urologic Research and Consulting LLC
Englewood, New Jersey, 07631, United States
Stony Brook University
Stony Brook, New York, 11794, United States
A.M.P. Radiation Oncology
Syracuse, New York, 13210, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Carolina Urology Partners
West Columbia, South Carolina, 29163, United States
Urology Associates
Nashville, Tennessee, 37209, United States
Rio Grande Urology
El Paso, Texas, 79912, United States
Seattle Urology Research Center
Burien, Washington, 98166, United States
Biospecimen
Formalin-fixed paraffin-embedded (FFPE) tissue from blocks or slides of prostatic adenocarcinoma biopsies
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 8 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2017
First Posted
September 25, 2017
Study Start
September 14, 2017
Primary Completion
January 14, 2022
Study Completion
January 14, 2022
Last Updated
June 23, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Within 1 year of last study out.
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.