Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-02-28 @ 4:57 AM
Study NCT ID:
NCT02450266
Status:
UNKNOWN
Last Update Posted:
2015-05-21
First Post:
2015-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing MRI/Ultrasound Fusion-guided Prostate Biopsy Versus Systematic Transrectal Ultrasound-guided 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': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 586}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2015-05-19', 'studyFirstSubmitQcDate': '2015-05-20', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rate of significant prostate cancers', 'timeFrame': 'One week after biopsy'}], 'secondaryOutcomes': [{'measure': 'Overall detection rate of prostate cancers', 'timeFrame': 'One week after biopsy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Primary disease', 'multiparametric MRI', 'targeted prostate biopsy', 'MRI/ultrasound fusion-guided prostate biopsy', 'systematic transrectal ultrasound-guided prostate biopsy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Patients will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound-guided prostate biopsy. In study arm B patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings.', 'detailedDescription': 'In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound fusion-guided biopsy improves the detection rates of significant prostate cancers compared with systematic transrectal ultrasound-guided prostate biopsy.\n\nMen with at least one previously negative transrectal ultrasound-guided biopsy and persistently elevated PSA values (\\> 3 ng/ml) or PSA velocity \\>0.75 ng/ml/p.a. will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to the gold-standard which comprises systematic transrectal ultrasound--guided prostate biopsy. In study arm B patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings. Targeted biopsies will be performed using MRI/ultrasound fusion-guided.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one negative transrectal ultrasound-guided prostate biopsy\n* PSA \\> 3.0 ng/ml or PSA velocity \\>0.75 ng/ml/p.a.\n\nExclusion Criteria:\n\n* Known prostate cancer\n* PSA \\>50 ng/ml\n* Previous MRI-targeted prostate biopsy'}, 'identificationModule': {'nctId': 'NCT02450266', 'acronym': 'PROFUSE', 'briefTitle': 'Study Comparing MRI/Ultrasound Fusion-guided Prostate Biopsy Versus Systematic Transrectal Ultrasound-guided Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Prospective Multicenter, Randomized Study Comparing the Diagnostic Efficacy of a Targeted MRI/Ultrasound Fusion-guided Prostate Biopsy Versus a Systematic Transrectal Ultrasound-guided Biopsy in Men With at Least on Negative Prostate Biopsy', 'orgStudyIdInfo': {'id': '004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A: Transrectal ultrasound-guided biopsy', 'description': 'Patients of arm A receive a systematic transrectal ultrasound-guided prostate biopsy (12-18 biopsy cores depending on individual prostate volume)', 'interventionNames': ['Device: Systematic transrectal ultrasound-guided prostate biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'B: MRI/ultrasound fusion-guided biopsy', 'description': 'Patients of arm B receive a targeted MRI/ultrasound fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.', 'interventionNames': ['Device: MRI/ultrasound fusion-guided prostate biopsy']}], 'interventions': [{'name': 'Systematic transrectal ultrasound-guided prostate biopsy', 'type': 'DEVICE', 'description': '12-18 systematic biopsy cores', 'armGroupLabels': ['A: Transrectal ultrasound-guided biopsy']}, {'name': 'MRI/ultrasound fusion-guided prostate biopsy', 'type': 'DEVICE', 'description': '2 targeted biopsy cores from each prostate lesion', 'armGroupLabels': ['B: MRI/ultrasound fusion-guided biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kurt Miller, MD', 'role': 'CONTACT', 'phone': '+49 30 8445 2575'}], 'facility': 'Department of Urology, Charité-Universitätsmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '40225', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Arsov, MD', 'role': 'CONTACT', 'email': 'christian.arsov@med.uni-duesseldorf.de', 'phone': '+49 211 8108607'}], 'facility': 'Department of Urology, University Hospital Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '07743', 'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marc O Grimm, MD', 'role': 'CONTACT', 'phone': '+49 3641-935206'}], 'facility': 'Department of Urology, University Hospital Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'centralContacts': [{'name': 'Christian Arsov, MD', 'role': 'CONTACT', 'email': 'christian.arsov@med.uni-duesseldorf.de', 'phone': '+49 211 8108607'}], 'overallOfficials': [{'name': 'Christian Arsov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Urology, University Hospital Düsseldorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Cancer Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}