Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-31 @ 9:05 PM
Study NCT ID:
NCT02237612
Status:
COMPLETED
Last Update Posted:
2014-09-11
First Post:
2014-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-09', 'studyFirstSubmitDate': '2014-09-04', 'studyFirstSubmitQcDate': '2014-09-09', 'lastUpdatePostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI', 'timeFrame': 'Baseline', 'description': 'Patients will be imaged using diffusion-weighted MR. Findings will be correlated with histopathologic findings at biopsy and/or prostatectomy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adenocarcinoma of the Prostate', 'Stage IIA Prostate Cancer', 'Stage IIB Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph nodes or other parts of the body. New imaging techniques, such as diffusion-weighted MRI, may be a less invasive way of predicting the stage and grade of prostate cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the sensitivity and specificity of diffusion-weighted MRI for pathologic T3 stage prostate cancer using a 3 Tesla (3T) magnet with a surface coil.\n\nOUTLINE:\n\nPatients undergo diffusion-weighted MRI of the pelvis.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy-documented adenocarcinoma of the prostate which is intermediate or high risk, defined as possessing one or more of the following features:\n\n * Gleason \\>= 7\n * \\> 50% biopsy cores +\n * Prostate-specific antigen (PSA) \\>= 10\n* Interested in undergoing a radical prostatectomy as definitive management for prostate cancer\n* No clinical or radiographic evidence for distant metastatic disease\n\n * In subjects with PSA \\< 20 no radiographic staging is required in the absence of clinical symptoms for distant metastatic disease; for those with PSA \\> 20, a bone scan must document lack of concern for bone involvement\n\nExclusion Criteria:\n\n* Ineligible for surgery due to cardiac, pulmonary, or other major comorbidity factor\n* History of claustrophobia\n* Pacemaker or other implanted metal objects which would make subject ineligible for MRI, per standard criteria\n* Unable to give written informed consent'}, 'identificationModule': {'nctId': 'NCT02237612', 'briefTitle': 'Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Diffusion-Weighted MRI for Staging in Localized Prostate Cancer: A Pilot Study', 'orgStudyIdInfo': {'id': '4P-08-4'}, 'secondaryIdInfos': [{'id': 'NCI-2014-01848', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'HS-08-00413-CR004'}, {'id': 'HS-08-00413'}, {'id': '4P-08-4', 'type': 'OTHER', 'domain': 'USC Norris Comprehensive Cancer Center'}, {'id': 'P30CA014089', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014089', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (diffusion-weighted MRI)', 'description': 'Patients undergo diffusion-weighted MRI of the pelvis.', 'interventionNames': ['Procedure: diffusion-weighted magnetic resonance imaging', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'diffusion-weighted magnetic resonance imaging', 'type': 'PROCEDURE', 'otherNames': ['diffusion-weighted MRI'], 'description': 'Undergo diffusion-weighted MRI', 'armGroupLabels': ['Diagnostic (diffusion-weighted MRI)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Diagnostic (diffusion-weighted MRI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Tanya Dorff', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}