Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT05137561
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2021-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed Cognitive Fusion TRUS Guided Prostate Biopsy (PROBIOP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-18', 'releaseDate': '2025-12-09'}], 'estimatedResultsFirstSubmitDate': '2025-12-09'}}, '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Simple randomization using RRApp'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2021-10-26', 'studyFirstSubmitQcDate': '2021-11-27', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy', 'timeFrame': '12 months', 'description': 'The number of participants (with percentages) in whom the biopsy procedure yielded a tissue specimen adequate for a definite pathological diagnosis and detection of PCa in both arms'}, {'measure': 'Diagnostic performance of mpMRI directed vs PET/CT directed prostate biopsy', 'timeFrame': '12 months', 'description': 'The sensitivity, specificity and accuracy of mpMR directed TRUS guided (cognitive fusion) and PSMA PET/CT directed biopsy will be compared.'}], 'secondaryOutcomes': [{'measure': 'Incidence of procedure related complications', 'timeFrame': 'three months', 'description': 'The procedure-related complications in the number and percentage of recruiting participants will be tabulated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Prostate Neoplasm']}, 'descriptionModule': {'briefSummary': 'The present study aimed to compare the diagnostic accuracy, radiation exposure, complication rates between 68Ga-PSMA PET/CT guided robotic arm assisted prostate biopsy and MRI directed TRUS guided prostate biopsy in PIRADS 4/5 lesions.', 'detailedDescription': 'To compare the diagnostic yield of Robotic-arm assisted 68Ga PSMA PET/CT guided prostate biopsy and MRI directed TRUS guided prostate biopsy in patients with PIRADS grading 4/5.\n\nTo compare the visual pain index of the patients between two arms during the procedure.\n\nTo compare the complication rates between the two arms during and after the procedure for a period of 2 weeks'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': 'Prostate cancer is malignancy of the male prostate.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. PIRADS 4 and 5 prostate lesions and PIRADS \\</= 3 prostate lesions with high clinical suspicion.\n2. Patients who are included in the study will be randomly allocated into either PSMA PET/CT guided biopsy or TRUS guided biopsy using simple randomization in RRApp\n\nExclusion Criteria:\n\n1. Patients with acute prostatitis/ urine culture positive.\n2. Patients with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2, and Platelet counts ≤ 80,000/mm3\n3. Patients who refuse to provide the written informed consent\n4. Non-cooperative patients'}, 'identificationModule': {'nctId': 'NCT05137561', 'acronym': 'PROBIOP', 'briefTitle': 'Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed Cognitive Fusion TRUS Guided Prostate Biopsy (PROBIOP)', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'Comparison of Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided (Cognitive Fusion) Prostate Biopsy in PIRADS 4 and 5 Lesions: A Pilot Study to Assess Diagnostic Performance and Patient Safety', 'orgStudyIdInfo': {'id': 'NK/7840/MD/624'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PSMA PET/CT guided biopsy arm', 'description': 'PSMA PET/CT guided biopsy will be done from PSMA avid lesion of the prostate after reviewing the whole body PSMA PET/CT scan.', 'interventionNames': ['Procedure: PSMA PET guided prostate biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MRI directed TRUS guided biopsy', 'description': 'The MRI-directed transrectal ultrasound-guided per-rectal prostate biopsy will be done by cognitive fusion.', 'interventionNames': ['Procedure: MRI directed TRUS guided prostate biopsy']}], 'interventions': [{'name': 'PSMA PET guided prostate biopsy', 'type': 'PROCEDURE', 'description': 'PSMA PET-guided prostate biopsy from PSMA avid prostatic lesion will be done.', 'armGroupLabels': ['PSMA PET/CT guided biopsy arm']}, {'name': 'MRI directed TRUS guided prostate biopsy', 'type': 'PROCEDURE', 'description': 'TRUS guided MR directed Cognitive fusion prostate biopsy based on the PIRADS scoring', 'armGroupLabels': ['MRI directed TRUS guided biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Chandigarh', 'country': 'India', 'facility': 'PGIMER', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Additional Professor', 'investigatorFullName': 'Rajender Kumar', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-12-09', 'type': 'RELEASE'}, {'date': '2025-12-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rajender Kumar, Additional Professor, Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}