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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03290508
Other study ID # URO-008
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 14, 2017
Est. completion date January 14, 2022

Study information

Verified date June 2022
Source Myriad Genetic Laboratories, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 524
Est. completion date January 14, 2022
Est. primary completion date January 14, 2022
Accepts healthy volunteers No
Gender Male
Age group 65 Years and older
Eligibility Inclusion Criteria: - Patients who have undergone CCP testing and patients who have not undergone CCP testing will be considered for enrollment in the study. 1. Willing to provide written informed consent. 2. Males =65 years old. 3. Newly diagnosed (=6 months), treatment-naïve patient with histologically proven localized adenocarcinoma of prostate whose initial treatment has not been decided. 4. Candidate for and considering AS and yet would be eligible for definitive therapy. 5. 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 6. Estimated life expectancy =10 years. 7. Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines). Exclusion Criteria: - 1. Clinical evidence of metastasis or lymph node involvement. - 2. Received pelvic radiation prior to biopsy. - 3. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitors (5-ARIs) are permitted. - 4. Participation in interventional clinical trials. - 5. Patient is considering watchful waiting. - 6. Has a known history of hypogonadism.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Prolaris Testing
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing

Locations

Country Name City State
United States Lehigh Valley Health Network Allentown Pennsylvania
United States University of Michigan, Department of Urologic Oncology Ann Arbor Michigan
United States Tufts Medical Center Boston Massachusetts
United States Seattle Urology Research Center Burien Washington
United States Medical University of South Carolina Charleston South Carolina
United States North Idaho Urology Coeur d'Alene Idaho
United States Pacific Urology Concord California
United States Premier Urology Cranford New Jersey
United States Premier Urology Group, LLC Cranford New Jersey
United States Advanced Urology Institute Daytona Beach Florida
United States Urology Group of Florida Delray Beach Florida
United States Rio Grande Urology El Paso Texas
United States Urologic Research and Consulting LLC Englewood New Jersey
United States Urology Centers of Alabama Homewood Alabama
United States Arkansas Urology Little Rock Arkansas
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States VA Long Beach Healthcare Long Beach California
United States East Valley Urology Center Mesa Arizona
United States Urology Associates Nashville Tennessee
United States UCI Medical Center Orange California
United States Associated Urologists of North Carolina Raleigh North Carolina
United States Comprehensive Urology Royal Oak Michigan
United States Pinellas Urology Saint Petersburg Florida
United States Ssg Md Apc San Jose California
United States Meridian Clinical Research Savannah Georgia
United States Regional Urology Shreveport Louisiana
United States Stony Brook University Stony Brook New York
United States 21st Century Oncology Sunrise Florida
United States A.M.P. Radiation Oncology Syracuse New York
United States Michigan Institute of Urology Troy Michigan
United States UroLogic Tupelo Mississippi
United States Carolina Urology Partners West Columbia South Carolina
United States URO Partners Westchester Illinois
United States Wichita Urology Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Myriad Genetic Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Low Prolaris Score, on Active Surveillance Proportion of patients with low Prolaris scores who are initially treated with active surveillance 3 years
Primary 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
Primary 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 Low Prolaris Score, Time to Definitive Treatment following Active Surveillance Time to definitive treatment in patients with low Prolaris scores who are initially treated with active surveillance. 8 years
Secondary No Prolaris Score, on Active Surveillance Proportion of patients without Prolaris testing who are initially treated with active surveillance. 3 years
Secondary No Prolaris Score, Definitive Treatment Following Active Surveillance Proportion of patients without Prolaris testing initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up. 3 years
Secondary No Prolaris Score, Time to Definitive Treatment Following Active Surveillance Time to definitive treatment in patients without Prolaris testing who are initially treated with Active Surveillance. 8 years
Secondary No Prolaris Score, Disease Progression Following Delayed Definitive Treatment 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. 8 years
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