Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Diagnostic Test: Prolaris Testing
- Registration Number
- NCT03290508
- Lead Sponsor
- Myriad Genetic Laboratories, Inc.
- 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.
- Detailed Description
This is a long-term prospective registry to evaluate the impact of Prolaris testing on therapeutic decisions in patients with newly diagnosed favorable intermediate-risk localized prostate cancer and to summarize clinical oncologic outcomes. The design of the study is non-interventional, and therefore the protocol will not require a specific treatment plan for study participants. However, in the absence of a universally accepted timeframe for repeat biopsies within existing active surveillance recommendations, study sites will be encouraged to monitor patients for disease progression as per the standard of care (e.g., current National Comprehensive Cancer Network \[NCCN\] guidelines) with the expectation of a repeat biopsy within 18 months of the initial biopsy.
Patients who undergo Prolaris testing will be included in the registry as well as patients who do not undergo Prolaris testing. Data collection for the first primary objective extends over a 3-year period. During this time, data is collected on the treatment initiated, any follow-up prostate biopsy performed in patients initially treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.
Data collection for the second primary objective extends out to 8 years. During this time data is collected on any follow-up prostate biopsy in patients still treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 524
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Patients who have undergone CCP testing and patients who have not undergone CCP testing will be considered for enrollment in the study.
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Willing to provide written informed consent.
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Males ≥65 years old.
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Newly diagnosed (≤6 months), treatment-naïve patient with histologically proven localized adenocarcinoma of prostate whose initial treatment has not been decided.
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Candidate for and considering AS and yet would be eligible for definitive therapy.
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Favorable intermediate-risk disease, defined by the NCCN as follows:
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predominant Gleason grade 3; AND
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percentage of positive cores <50%; AND
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no more than 1 of the following NCCN intermediate-risk factors:
- Gleason grade 7
- T2b-T2c
- PSA 10-20 ng/mL
-
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Estimated life expectancy ≥10 years.
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Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).
-
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- Clinical evidence of metastasis or lymph node involvement.
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- Received pelvic radiation prior to biopsy.
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- Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitors (5-ARIs) are permitted.
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- Participation in interventional clinical trials.
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- Patient is considering watchful waiting.
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- Has a known history of hypogonadism.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prolaris Testing Prolaris Testing Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing
- Primary Outcome Measures
Name Time Method Low Prolaris Score, Disease Progression Following Delayed Definitive Treatment 8 years 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.
Low Prolaris Score, Definitive Treatment Following Active Surveillance 3 years Proportion of patients with low Prolaris scores and initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up
Low Prolaris Score, on Active Surveillance 3 years Proportion of patients with low Prolaris scores who are initially treated with active surveillance
- Secondary Outcome Measures
Name Time Method No Prolaris Score, Time to Definitive Treatment Following Active Surveillance 8 years Time to definitive treatment in patients without Prolaris testing who are initially treated with Active Surveillance.
No Prolaris Score, on Active Surveillance 3 years Proportion of patients without Prolaris testing who are initially treated with active surveillance.
Low Prolaris Score, Time to Definitive Treatment following Active Surveillance 8 years Time to definitive treatment in patients with low Prolaris scores who are initially treated with active surveillance.
No Prolaris Score, Definitive Treatment Following Active Surveillance 3 years Proportion of patients without Prolaris testing initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up.
No Prolaris Score, Disease Progression Following Delayed Definitive Treatment 8 years Proportion of patients without Prolaris testing and initially treated with active surveillance who proceed with definitive treatment that develop disease progression at 5 years subsequent to the start of definitive treatment.
Trial Locations
- Locations (34)
Urology Group of Florida
🇺🇸Delray Beach, Florida, United States
A.M.P. Radiation Oncology
🇺🇸Syracuse, New York, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
21st Century Oncology
🇺🇸Sunrise, Florida, United States
Arkansas Urology
🇺🇸Little Rock, Arkansas, United States
UCI Medical Center
🇺🇸Orange, California, United States
Ssg Md Apc
🇺🇸San Jose, California, United States
URO Partners
🇺🇸Westchester, Illinois, United States
Regional Urology
🇺🇸Shreveport, Louisiana, United States
Comprehensive Urology
🇺🇸Royal Oak, Michigan, United States
UroLogic
🇺🇸Tupelo, Mississippi, United States
Advanced Urology Institute
🇺🇸Daytona Beach, Florida, United States
Michigan Institute of Urology
🇺🇸Troy, Michigan, United States
VA Long Beach Healthcare
🇺🇸Long Beach, California, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Pinellas Urology
🇺🇸Saint Petersburg, Florida, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Meridian Clinical Research
🇺🇸Savannah, Georgia, United States
Stony Brook University
🇺🇸Stony Brook, New York, United States
Wichita Urology
🇺🇸Wichita, Kansas, United States
Carolina Urology Partners
🇺🇸West Columbia, South Carolina, United States
East Valley Urology Center
🇺🇸Mesa, Arizona, United States
Associated Urologists of North Carolina
🇺🇸Raleigh, North Carolina, United States
North Idaho Urology
🇺🇸Coeur d'Alene, Idaho, United States
Pacific Urology
🇺🇸Concord, California, United States
Premier Urology Group, LLC
🇺🇸Cranford, New Jersey, United States
Urologic Research and Consulting LLC
🇺🇸Englewood, New Jersey, United States
Seattle Urology Research Center
🇺🇸Burien, Washington, United States
Premier Urology
🇺🇸Cranford, New Jersey, United States
Rio Grande Urology
🇺🇸El Paso, Texas, United States
Urology Associates
🇺🇸Nashville, Tennessee, United States
University of Michigan, Department of Urologic Oncology
🇺🇸Ann Arbor, Michigan, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States