Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT03511235
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2018-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 774}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2018-04-17', 'studyFirstSubmitQcDate': '2018-04-17', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of BCR or metastasis after selection of active surveillance (AS)', 'timeFrame': 'Up to five years post Prolaris report', 'description': 'This study will evaluate how frequently men with low disease-specific mortality (DSM) risk based on Prolaris CCR score and who meet NCCN low-risk criteria initially select AS (AS selection). This study also will assess how long Prolaris-tested men who initially select AS remain on this course before proceeding to definitive treatment (AS durability), and whether AS duration impacts biochemical recurrence (BCR) and metastasis risk in these men.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Medicare is requesting outcome data on patients who received Prolaris testing and were prescribed active surveillance (AS). In order to ensure appropriate patient care, it is important to understand how this added prognostic information influences the selection and durability of AS and corresponding clinical outcomes. To address this knowledge gap, this study will evaluate how frequently men with low disease-specific mortality (DSM) risk based on Prolaris CCR score and who meet NCCN low-risk criteria initially select AS (AS selection). This study also will assess how long Prolaris-tested men who initially select AS remain on this course before proceeding to definitive treatment (AS durability), and whether AS duration impacts biochemical recurrence (BCR) and metastasis risk in these men. This retrospective, observational and multi-site study will combine patient CCR scores with longitudinal clinical data to address these questions.', 'detailedDescription': "This is a multicenter, retrospective, observational study in men diagnosed with localized PrCa who had Prolaris testing prior to the treatment decision. The study will collect demographic, clinical, pathologic, and Prolaris test data from medical records and Myriad's Prolaris database.\n\nThe primary objective of this study is to evaluate the rate of BCR or metastasis, whichever occurs first, among Prolaris-tested men who were at low risk of DSM (≤3.2%), who also met NCCN low-risk criteria, and who were initially treated with AS.\n\nThe secondary objectives of the study are to evaluate the frequency of AS selection among all men who had low DSM risk, as determined by Prolaris testing and AS durability among Prolaris-tested men with low DSM risk who selected and initiated this treatment."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prolaris-tested men diagnosed with low-risk prostate cancer.', 'genderDescription': 'Not based on self-representation of gender identity', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with localized PrCa at participating sites between January 1, 2013 and August 1, 2017.\n* Have undergone Prolaris testing and have a CCR score with estimated DSM risk ≤3.2%.\n* Have NCCN low-risk disease2.\n\nExclusion Criteria:\n\n* Received any therapy other than 5α-reductase inhibitor (5-ARI) prior to diagnostic biopsy.\n* Over 80 years of age at diagnosis.\n* History of hypogonadism at the time of diagnosis.\n* Co-occurring malignancy, excluding non-melanoma skin cancer.\n* Enrolled in another investigational study.'}, 'identificationModule': {'nctId': 'NCT03511235', 'acronym': 'URO-009Low', 'briefTitle': 'Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Myriad Genetic Laboratories, Inc.'}, 'officialTitle': 'Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing', 'orgStudyIdInfo': {'id': 'URO-009'}}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Urology', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Urology', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Kar Urology', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Golden Gate Urology', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Urological Associates', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Urology Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63367', 'city': 'Lake Saint Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Dr. Jeffrey Glaser, Urologist', 'geoPoint': {'lat': 38.79755, 'lon': -90.78568}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloane Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Bryan M Dechairo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Myriad Genetics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Myriad Genetic Laboratories, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}