Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 5:32 PM
Study NCT ID:
NCT01024959
Status:
COMPLETED
Last Update Posted:
2012-11-12
First Post:
2009-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.reid@hologic.com', 'phone': '858-731-5985', 'title': 'Jennifer Reid, Director of Clinical Affairs', 'organization': 'Gen-Probe, Incorporated'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Our definition of at risk population is any unique subject who gave a post-digital rectal exam (DRE) urine sample, regardless of eligibility(n=498 of n=507 participants who started the study). n=106 of these subjects had a positive biopsy; n=389 had negative biopsy; n=3 had no biopsy.', 'eventGroups': [{'id': 'EG000', 'title': 'PCA3 Assay', 'description': 'PCA3 Assay : Post-DRE urine collected prior to prostate biopsy', 'otherNumAtRisk': 498, 'otherNumAffected': 0, 'seriousNumAtRisk': 498, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Subjects With Positive Biopsy Result', 'description': 'Presence of prostate cancer defined by one or more positive biopsy cores', 'otherNumAtRisk': 106, 'otherNumAffected': 0, 'seriousNumAtRisk': 106, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Subjects With Negative Biopsy Result', 'description': 'Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)', 'otherNumAtRisk': 389, 'otherNumAffected': 0, 'seriousNumAtRisk': 389, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Subjects With no Biopsy Performed', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PCA3 Assay', 'description': 'PCA3 Assay : Post-DRE urine collected prior to prostate biopsy'}, {'id': 'OG001', 'title': 'Subjects With Positive Biopsy Result', 'description': 'Presence of prostate cancer defined by one or more positive biopsy cores'}, {'id': 'OG002', 'title': 'Subjects With Negative Biopsy Result', 'description': 'Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)'}], 'classes': [{'title': 'All PCA3 Scores', 'categories': [{'measurements': [{'value': '466', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '364', 'groupId': 'OG002'}]}]}, {'title': 'PCA3 Score >=25', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}]}, {'title': 'PCA3 Score <25', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of biopsy', 'description': 'The likelihood of positive biopsy was determined by the PCA3 Score expressed as a binary categorical variable: PCA3 Score \\>=25 was positive, PCA3 Score \\<25 was negative', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of n=466 subjects have valid and reportable PCA3 Scores and disease status (determined by biopsy result), and who were 50 years of age or older.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prostate Cancer Gene 3 (PCA3) Assay', 'description': 'PCA3 Assay : Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '507'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '466'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'results not evaluable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'missing results required for analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}]}], 'recruitmentDetails': '507 male subjects were recruited from 14 clinical sites in the United States including academic institutions, community-based urology clinics and group health organizations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PCA3 Assay', 'description': 'PCA3 Assay : Post-DRE urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'spread': '8.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '495', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '495', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 507}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-06', 'studyFirstSubmitDate': '2009-12-01', 'resultsFirstSubmitDate': '2012-10-08', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-08', 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)', 'timeFrame': 'At the time of biopsy', 'description': 'The likelihood of positive biopsy was determined by the PCA3 Score expressed as a binary categorical variable: PCA3 Score \\>=25 was positive, PCA3 Score \\<25 was negative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Prostate Biopsy', 'PCA3'], 'conditions': ['Prostatic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '23416644', 'type': 'DERIVED', 'citation': 'Gittelman MC, Hertzman B, Bailen J, Williams T, Koziol I, Henderson RJ, Efros M, Bidair M, Ward JF. PCA3 molecular urine test as a predictor of repeat prostate biopsy outcome in men with previous negative biopsies: a prospective multicenter clinical study. J Urol. 2013 Jul;190(1):64-9. doi: 10.1016/j.juro.2013.02.018. Epub 2013 Feb 14.'}]}, 'descriptionModule': {'briefSummary': "The objective of this multi-center clinical study is to determine the association of the PCA3 Score with prostate biopsy outcome and validate the assay's performance characteristics in men with previous negative prostate biopsies. An elevated PCA3 Score is thought to be associated with an increased likelihood of positive biopsy. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test.", 'detailedDescription': "PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination. Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen (PSA) testing. Gen-Probe's PROGENSA(R) PCA3 assay is the first urine-based molecular diagnostic assay for prostate cancer."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men 40+ years of age who have had at least 1 previous negative prostate biopsy, who have never had a positive prostate biopsy, and who have been recommended for a repeat biopsy by their clinician.\n* The subject must be able to comprehend and sign an approved informed consent form and other applicable study enrollment documents\n\nExclusion Criteria:\n\n* Use of medications or hormones that are known to affect serum PSA levels within 3 - 6 months of study enrollment\n* Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment\n* History of prostate cancer\n* History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary tract symptoms within 6 months of study enrollment\n* Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject\n* Participation in pharmaceutical or treatment related clinical study within 6 months of study enrollment. Exception: Trials for non-prostate conditions may be acceptable, with approval by the investigator and Sponsor'}, 'identificationModule': {'nctId': 'NCT01024959', 'acronym': 'PCA3', 'briefTitle': 'Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gen-Probe, Incorporated'}, 'officialTitle': 'Clinical Evaluation of the PROGENSA(R) PCA3 Assay in Men With a Previous Negative Biopsy Result', 'orgStudyIdInfo': {'id': '2009PCA301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCA3 Assay', 'interventionNames': ['Other: PCA3 Assay']}], 'interventions': [{'name': 'PCA3 Assay', 'type': 'OTHER', 'description': 'Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy', 'armGroupLabels': ['PCA3 Assay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90015', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'HealthCare Partners Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Clinical Trials', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Medical Research', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Specialists in Urology', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '34237', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Urology Specialists', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '47130', 'city': 'Jeffersonville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Metropolitan Urology, PSC', 'geoPoint': {'lat': 38.27757, 'lon': -85.73718}}, {'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Regional Urology Specialists, LLC', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '11530', 'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'facility': 'AccuMed Research Associates', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'TriState Urologic Services PSC Inc. dba The Urology Group', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43220', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Columbus Urology Research, LLC', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology San Antonio Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Urology', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Jennifer Reid, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gen-Probe, Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gen-Probe, Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}