Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-25 @ 4:44 PM
Study NCT ID:
NCT06027203
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2023-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transperineal Versus Transrectal 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 923}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2023-09-05', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications', 'timeFrame': '2 weeks', 'description': 'Urinary tract infections, urinary retention, hematuria'}], 'secondaryOutcomes': [{'measure': 'Detection rate', 'timeFrame': '2 weeks', 'description': 'Chance of detecting prostate cancer according to histopathology of needle biopsy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate biopsy', 'prostate cancer', 'transperineal', 'transrectal'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Background: Prostate biopsies are essential to diagnose prostate cancer (PCa). Transrectal prostate biopsies (TR-PB) are commonly performed, however disadvantages include the requirement of antibiotic prophylaxis (AP) and higher complication rates than transperineal prostate biopsies (TP-PB). Guidelines still recommend the use of AP for TP-PB due to the limited evidence regarding complication rates after their omission. However, the rising rates of antibiotic resistance is of concern. The aim of this study was to compare the complication and detection rates of freehand TP-PB without AP versus TR-PB with AP.\n\nMethods: This single center retrospective study was performed in an academic hospital. TP-PB were introduced in 2019 and implemented as the main technique by late 2020. To compare the two techniques, data was collected for freehand TR-PB with AP between 2017-2018 and freehand TP-PB without AP between 2021-2022. The data from 2019 and 2020 were excluded to rule out the effects of the initial learning curve during the transition period. Primary outcome measure was post-biopsy complications occurring within 2 weeks, focusing on infectious complications. Secondary outcome measures were detection rates and upgrading/reclassification in the repeat biopsy in active surveillance (AS). Statistical analysis was performed using a Fisher exact or Chi-Squared test.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All men who underwent a transrectal prostate biopsy between January 2017 and December 2018, and/or a transperineal prostate biopsy between January 2021 and December 2022 in the Urology department of MUMC+', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men who underwent prostate biopsy between 2017-2018 (transrectal)\n* men who underwent prostate biopsy between 2012-2022 (transperineal)\n\nExclusion Criteria:\n\n* positive urine culture before biopsy\n* patients in the transrectal biopsy group who did not take the prescribed course of antibiotic prophylaxis\n* incomplete medical dossier where the occurrence of a complication could not be assessed'}, 'identificationModule': {'nctId': 'NCT06027203', 'briefTitle': 'Transperineal Versus Transrectal Prostate Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Freehand Transperineal Prostate Biopsies Without Antibiotic Prophylaxis - the New Gold Standard?', 'orgStudyIdInfo': {'id': 'MUMC-Pbx23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'transrectal biopsy', 'interventionNames': ['Procedure: prostate biopsy']}, {'label': 'transperineal biopsy', 'interventionNames': ['Procedure: prostate biopsy']}], 'interventions': [{'name': 'prostate biopsy', 'type': 'PROCEDURE', 'description': 'Prostate biopsy by either transrectal or transperineal technique', 'armGroupLabels': ['transperineal biopsy', 'transrectal biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}