Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04299620
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-06
First Post:
2020-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-09', 'mcpReleaseN': 10, 'releaseDate': '2023-12-15'}], 'estimatedResultsFirstSubmitDate': '2023-12-15'}}, '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': 'D036761', 'term': 'Ultrasound, High-Intensity Focused, Transrectal'}], 'ancestors': [{'id': 'D057086', 'term': 'High-Intensity Focused Ultrasound Ablation'}, {'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ex vivo and in vivo micro-US images', 'timeFrame': 'Up to 3 years', 'description': 'Differences in in vivo versus ex vivo image quality will be evaluated by testing for systematic differences in tumor contouring accuracy. The measures will be identical to those listed under "secondary outcome measures" above, but for comparison between ex vivo micro ultrasound and in vivo micro ultrasound (instead of MRI).'}, {'measure': 'Suspicion of extracapsular extension (ECE)', 'timeFrame': 'Up to 3 years', 'description': 'Micro ultrasound and mpMRI ECE suspicion scores will be compared for ECE-positive tumors. Micro ultrasound and mpMRI ECE suspicion scores will also be compared for ECE-negative tumors.\n\nMeasurement tool(s) = Wilcoxon signed-rank test and one-sided non-inferiority t-test.\n\nNotes on the use of Wilcoxon signed-rank tests: (see outcome 2 description above)'}], 'primaryOutcomes': [{'measure': 'Identification of prostate cancer foci', 'timeFrame': 'Up to 3 years', 'description': 'Will be evaluated by comparing sensitivity and positive predictive value of multiparametric magnetic resonance imaging (mpMRI) and micro-ultrasound (US) for identification of prostate cancer (CaP) foci.\n\nMeasurement tool = chi squared test'}], 'secondaryOutcomes': [{'measure': 'Contours of prostate cancer foci', 'timeFrame': 'Up to 3 years', 'description': 'evaluated by measuring the dice similarity coefficient (DSC) and Hausdorff distances (Hd) between micro-ultrasound (US) and whole mount (WM) tumor contours, and between mpMRI and WM tumor contours. The difference between tumor diameter and volume will be computed between WM and mpMRI, and between WM and US. All measures will then be used to compare accuracy of US versus mpMRI.\n\nWilcoxon signed-rank tests:\n\nSigned rank tests are nonparametric matched pair tests, here mostly used to compare correlation of mpMRI and WM v. correlation of US and WM. Minimum and maximum input values will depend on the metric being tested; min and max output values will vary between zero and one. A higher output indicates less difference in performance between mpMRI and US. A lower score indicates that more a difference between mpMRI and US. Whether a lower score is a better outcome or worse outcome depends on which modality (mpMRI vs US) is more strongly correlated with WM.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Carcinoma']}, 'descriptionModule': {'briefSummary': 'This trial studies the ability of micro-ultrasound to detect and characterize prostate cancer tumors in patients undergoing radical prostatectomy (removal of the entire prostate and some of the tissue around it). Usually multiparametric magnetic resonance imaging is used for the detection and targeted therapy of prostate cancer, but its accuracy remains imperfect. Micro-ultrasound may be superior as it provides real-time tumor visualization which may simplify and improve prostate cancer targeted therapy. This may also reduce the need for and substantial costs of radical prostatectomy.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Determine if micro-ultrasound (US) can be used to identify prostate cancer foci with equivalent (non-inferior) performance relative to multiparametric magnetic resonance imaging (mpMRI).\n\nSECONDARY OBJECTIVE:\n\nI. Determine if micro-US can be used to contour prostate cancer foci with equivalent (non-inferior) accuracy to mpMRI.\n\nTERTIARY OBJECTIVE:\n\nI. Determine if ex vivo micro-US images have quality comparable to in vivo micro-US images.\n\nQUATERNARY OBJECTIVE:\n\nI. Determine if micro-US can be used to evaluate suspicion of extracapsular extension (ECE) with equivalent (non-inferior) accuracy to mpMRI.\n\nOUTLINE:\n\nPatients may undergo transrectal micro-ultrasound scan (TRUS) prior to standard-of-care radical prostatectomy. Following radical prostatectomy, removed glands are scanned and micro-US, standard of care mpMRI, and whole mount images are analyzed and compared.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Standard-of-care mpMRI within the past 12 months\n* Biopsy-proven prostate cancer, Gleason grade \\>= 3+3\n* Maximum posterior-to-anterior prostate dimension of =\\< 6 cm\n* Scheduled to receive standard-of-care radical prostatectomy\n\nExclusion Criteria:\n\n* Maximum posterior-to-anterior prostate dimension greater than 6 cm\n* Prior radiation or focal treatment for prostate cancer\n* Inability to have a transrectal ultrasound scan\n* Prostate biopsy \\< 4 weeks prior to surgery'}, 'identificationModule': {'nctId': 'NCT04299620', 'briefTitle': 'Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'Micro-Ultrasound to Whole Mount Image Correlation for Detection and Localization of Prostate Cancer', 'orgStudyIdInfo': {'id': '19-001136'}, 'secondaryIdInfos': [{'id': 'NCI-2019-05784', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '19-001136', 'type': 'OTHER', 'domain': 'UCLA / Jonsson Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (TRUS)', 'description': 'Patients may undergo TRUS prior to standard-of-care radical prostatectomy. Following radical prostatectomy, removed glands are scanned and micro-US, standard of care mpMRI, and whole mount images are analyzed and compared.', 'interventionNames': ['Device: Digital Image Analysis', 'Procedure: Radical Prostatectomy', 'Procedure: Transrectal Ultrasound']}], 'interventions': [{'name': 'Digital Image Analysis', 'type': 'DEVICE', 'description': 'Analysis of images', 'armGroupLabels': ['Diagnostic (TRUS)']}, {'name': 'Radical Prostatectomy', 'type': 'PROCEDURE', 'otherNames': ['Prostatovesiculectomy'], 'description': 'Undergo standard of care radical prostatectomy', 'armGroupLabels': ['Diagnostic (TRUS)']}, {'name': 'Transrectal Ultrasound', 'type': 'PROCEDURE', 'otherNames': ['endorectal ultrasound', 'ERUS (endorectal ultrasound)', 'TRUS'], 'description': 'Undergo transrectal ultrasound', 'armGroupLabels': ['Diagnostic (TRUS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA / Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Leonard S Marks', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA / Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Exact Imaging', 'class': 'INDUSTRY'}, {'name': 'Phase One Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}