Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT01594502
Status:
COMPLETED
Last Update Posted:
2020-10-12
First Post:
2012-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068538', 'term': 'Dutasteride'}], 'ancestors': [{'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-09', 'studyFirstSubmitDate': '2012-04-17', 'studyFirstSubmitQcDate': '2012-05-07', 'lastUpdatePostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue.', 'timeFrame': 'Year 4'}], 'secondaryOutcomes': [{'measure': 'Multivariable treatment-response score between subjects who develop PCa while on dutasteride and those who do not.', 'timeFrame': 'Year 4'}, {'measure': 'Magnitude of association between nuclear phenotype in benign biopsies, and subsequent risk of PCa in untreated men at elevated risk.', 'timeFrame': 'Year 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'dutasteride'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to apply cutting-edge imaging approaches, incorporating machine-learning for pattern recognition and multispectral analysis, to the development and validation of intermediate endpoint biomarkers in benign tissue that characterize the response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer among men with negative biopsies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Probability Sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* completed REDUCE trial (Year 4 exit biopsy with blocks and HE slides available; i.e., U.S. participants only)\n* compliant with assigned treatment based on either: (dutasteride group) at least 3 post-baseline serum DHT levels ≥ 50% lower than baseline, or (placebo group) at least 3 post-baseline serum DHT levels with none showing ≥ 50% decrease from baseline\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT01594502', 'briefTitle': 'Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies', 'orgStudyIdInfo': {'id': '2010-0670'}, 'secondaryIdInfos': [{'id': 'R01CA155301', 'link': 'https://reporter.nih.gov/quickSearch/R01CA155301', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dutasteride Year 2 PCa', 'description': 'Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy.', 'interventionNames': ['Drug: Dutasteride']}, {'label': 'Placebo Year 2 no PCa, Year 4 PCa', 'description': 'Subject assigned to placebo, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.', 'interventionNames': ['Drug: Placebo']}, {'label': 'Dutasteride Year 2 no PCa, Year 4 PCa', 'description': 'Subject assigned to dutasteride, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.', 'interventionNames': ['Drug: Dutasteride']}, {'label': 'Placebo, Year 2 and 4 no PCa', 'description': 'Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy.', 'interventionNames': ['Drug: Placebo']}, {'label': 'Dutasteride, Year 2 and 4 no PCa', 'description': 'Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy.', 'interventionNames': ['Drug: Dutasteride']}, {'label': 'Placebo, Year 2 PCa', 'description': 'Subject assigned to placebo, prostate cancer found on Year 2 biopsy.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dutasteride', 'type': 'DRUG', 'description': '0.5 mg daily', 'armGroupLabels': ['Dutasteride Year 2 PCa', 'Dutasteride Year 2 no PCa, Year 4 PCa', 'Dutasteride, Year 2 and 4 no PCa']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Comparator', 'armGroupLabels': ['Placebo Year 2 no PCa, Year 4 PCa', 'Placebo, Year 2 PCa', 'Placebo, Year 2 and 4 no PCa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Peter H Gann, MD, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director, Division of Pathology Research', 'investigatorFullName': 'Peter Gann', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}