Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT04953351
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2021-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MRI-Ultrasound Fusion or Cognitive Registration in MR-targeted Prostate Biopsy
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 470}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-01', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rates of clinically significant PCa in FUS-TB and COG-TB', 'timeFrame': 'When histology results available, at an expected average of 30 days post-biopsy'}], 'secondaryOutcomes': [{'measure': 'Detection rates of clinically insignificant PCa in FUS-TB and COG-TB', 'timeFrame': 'When histology results available, at an expected average of 30 days post-biopsy'}, {'measure': 'Detection rates of clinically insignificant PCa in men with MRI score 3, 4 or 5', 'timeFrame': 'When histology results available, at an expected average of 30 days post-biopsy'}, {'measure': 'Cancer core length of the most involved biopsy core (maximum cancer core length)', 'timeFrame': 'When histology results available, at an expected average of 30 days post-biopsy'}, {'measure': 'Biopsy-related adverse events', 'timeFrame': '30 days post biopsy'}, {'measure': 'Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading', 'timeFrame': '60 days post biopsy'}, {'measure': 'Detection rates of clinically significant PCa in SB', 'timeFrame': 'When histology results available, at an expected average of 30 days post-biopsy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-ultrasound fusion targeted biopsy compared to cognitive registration targeted biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.', 'detailedDescription': 'Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa).\n\nWith the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (MRI-TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-system biopsy (SB). MRI-ultrasound fusion TB (FUS-TB) and cognitive registration TB (COG-TB) are two techniques of MRI-TB commonly used. However, the optimal methodology for targeting MRI-suspicious regions remains unknown. The accuracy of COG-TB compared with FUS-TB remains unclear.\n\nThis randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of COG-TB compared to FUS-TB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men more than 18 years old with clinical suspicion of prostate cancer;\n2. Serum PSA ≤ 20 ng/ml within the previous 3 months;\n3. Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months;\n4. No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;\n5. mpMRI PI-RADS V2.1 score ≥3；\n6. Able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Prior prostate biopsy or prostate surgery;\n2. Prior treatment for prostate cancer;\n3. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);\n4. Contraindication to prostate biopsy;\n5. Men in whom artifact would reduce the quality of the MRI.'}, 'identificationModule': {'nctId': 'NCT04953351', 'acronym': 'PROMUC', 'briefTitle': 'MRI-Ultrasound Fusion or Cognitive Registration in MR-targeted Prostate Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'PROMUC Trial-Comparison of Magnetic Resonance Imaging-Ultrasound Fusion and Cognitive Registration in MR-targeted Prostate Biopsy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MRITB-202003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cognitive registration targeted biopsy', 'interventionNames': ['Procedure: Cognitive registration targeted biopsy and TRUS-system biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MRI-ultrasound fusion targeted biopsy', 'interventionNames': ['Procedure: MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy']}], 'interventions': [{'name': 'Cognitive registration targeted biopsy and TRUS-system biopsy', 'type': 'PROCEDURE', 'description': 'Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on ultrasound that corresponds to the MRI suspicious regions location. TRUS-system biopsy includes 12 biopsy cores.', 'armGroupLabels': ['cognitive registration targeted biopsy']}, {'name': 'MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy', 'type': 'PROCEDURE', 'description': 'MRI-ultrasound fusion targeted biopsy is conducted with an mpMRI-TRUS biopsy system that provides realtime fusion of TRUS images and MRI images to guide the biopsy needles. TRUS-system biopsy includes 12 biopsy cores.', 'armGroupLabels': ['MRI-ultrasound fusion targeted biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Hongqian Guo, PhD', 'role': 'CONTACT', 'email': 'dr.ghq@nju.edu.cn', 'phone': '8613605171690'}, {'name': 'Qun Lu, PhD', 'role': 'CONTACT', 'email': 'luqun_1989@126.com', 'phone': '8615195856020'}], 'overallOfficials': [{'name': 'Hongqian Guo, Guo', 'role': 'STUDY_CHAIR', 'affiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University', 'investigatorFullName': 'Hongqian Guo', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}