Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-28 @ 4:11 AM
Study NCT ID:
NCT04843566
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2021-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'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': 'D019072', 'term': 'Antibiotic Prophylaxis'}], 'ancestors': [{'id': 'D018890', 'term': 'Chemoprevention'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011292', 'term': 'Premedication'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jch9011@med.cornell.edu', 'phone': '2127463418', 'title': 'Jim Hu', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '10 days post biopsy procedure date', 'description': 'Only subjects that were included in the intent to treat analysis were evaluated for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Transrectal', 'description': 'Patients will receive a transrectal MRI-guided prostate biopsy.\n\nTransrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.\n\nAntibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).\n\nNo antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.', 'otherNumAtRisk': 280, 'deathsNumAtRisk': 280, 'otherNumAffected': 8, 'seriousNumAtRisk': 280, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Transperineal', 'description': 'Patients will receive a transperineal MRI-guided prostate biopsy.\n\nTransperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.', 'otherNumAtRisk': 287, 'deathsNumAtRisk': 287, 'otherNumAffected': 1, 'seriousNumAtRisk': 287, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 287, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 287, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects That Experienced Infection, Urinary Retention or Bleeding Requiring Intervention Within 7 Days of Biopsy Based on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transrectal', 'description': 'Patients will receive a transrectal MRI-guided prostate biopsy.\n\nTransrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.\n\nAntibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).\n\nNo antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.'}, {'id': 'OG001', 'title': 'Transperineal', 'description': 'Patients will receive a transperineal MRI-guided prostate biopsy.\n\nTransperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.'}], 'classes': [{'title': 'Infection', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Retention', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Bleeding requiring intervention', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Infection', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Urinary retention', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Bleeding requiring intervention', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '7 days post-biopsy', 'description': 'Outcome measure Description Now says: Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ) is a validated biopsy questionnaire that measures adverse events that have occurred due to infection. Patient questionnaires that reported infection complications and duration of symptoms, had their electronic medical records verified to confirm if an infection occurred or not.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the transrectal arm that underwent a transperineal biopsy or withdrew were excluded from analysis. Subjects in the transperineal arm that underwent a transrectal biopsy or withdrew were excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patient Reporting Biopsy Pain and Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transrectal', 'description': 'Patients will receive a transrectal MRI-guided prostate biopsy.\n\nTransrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.\n\nAntibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).\n\nNo antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.'}, {'id': 'OG001', 'title': 'Transperineal', 'description': 'Patients will receive a transperineal MRI-guided prostate biopsy.\n\nTransperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.'}], 'classes': [{'title': 'Immediately following biopsy - pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Immediately following biopsy - discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}, {'title': '7-day post biopsy - pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}, {'title': '7-day post biopsy - discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Immediately following biopsy - Pain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Immediately following biopsy - Discomfort', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '7-day post biopsy - Pain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '7-day post biopsy - Discomfort', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately following biopsy, 7 days post-biopsy', 'description': 'Patient reported pain via a yes/no questionnaire', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Subjects in the transrectal arm that underwent a transperineal biopsy or withdrew were excluded from analysis. Subjects in the transperineal arm that underwent a transrectal biopsy or withdrew were excluded from analysis. Any subject that didn't complete a questionnaire was excluded from analysis."}, {'type': 'SECONDARY', 'title': 'Change in Patient-reported Anxiety, as Measured on a 0-10 Likert Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transrectal', 'description': 'Patients will receive a transrectal MRI-guided prostate biopsy.\n\nTransrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.\n\nAntibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).\n\nNo antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.'}, {'id': 'OG001', 'title': 'Transperineal', 'description': 'Patients will receive a transperineal MRI-guided prostate biopsy.\n\nTransperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following biopsy', 'description': 'Anxiety will be scored on a 0-10 Likert scale. 0 indicates no anxiety and high scores indicate greater anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Subjects in the transrectal arm that underwent a transperineal biopsy or withdrew were excluded from analysis. Subjects in the transperineal arm that underwent a transrectal biopsy or withdrew were excluded from analysis. Any subject that didn't complete a questionnaire was excluded from analysis."}, {'type': 'SECONDARY', 'title': 'Detection of Clinically Significant Disease as Measured by Gleason Grade Group ≥ 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transrectal', 'description': 'Patients will receive a transrectal MRI-guided prostate biopsy.\n\nTransrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.\n\nAntibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).\n\nNo antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.'}, {'id': 'OG001', 'title': 'Transperineal', 'description': 'Patients will receive a transperineal MRI-guided prostate biopsy.\n\nTransperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.'}], 'classes': [{'title': 'Gleason grade group ≥ 2', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}, {'title': 'Gleason grade group 1', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'No Gleason Score', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Gleason grade \\>=2', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post-biopsy', 'description': 'Gleason Grade Group is a prostate cancer grading system released by the International Society of Urological Pathology (ISUP). Grade Group 1 indicates Low/Very Low Risk, Grade Group 2 indicates Intermediate (Favorable) Risk, Grade Group 3 indicates Intermediate (Unfavorable) Risk, and Grade Groups 4 and 5 indicate High/Very High Risk.\n\nProstate cancer grade will be categorized into insignificant (Gleason Grade Group 1) and clinically significant (Grade Group ≥ 2).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the transrectal arm that underwent a transperineal biopsy or withdrew were excluded from analysis. Subjects in the transperineal arm that underwent a transrectal biopsy or withdrew were excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Adverse Events, as Measured on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transrectal', 'description': 'Patients will receive a transrectal MRI-guided prostate biopsy.\n\nTransrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.\n\nAntibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).\n\nNo antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.'}, {'id': 'OG001', 'title': 'Transperineal', 'description': 'Patients will receive a transperineal MRI-guided prostate biopsy.\n\nTransperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.'}], 'classes': [{'title': 'Infection', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Retention', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bleeding requiring intervention', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Infection', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Urinary retention', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Bleeding requiring intervention', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post-biopsy', 'description': 'Transrectal Ultrasound Guided prostate Biopsy Questionnaire (TRUS-BxQ) is a validated biopsy questionnaire that measures adverse events that have occurred, such as hospital re-admissions, aborted procedures due to discomfort, hematuria, urinary retention, hematospermia, and/or hematochezia. Patient questionnaire consists of Yes/No questions about general complications and duration of adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the transrectal arm that underwent a transperineal biopsy or withdrew were excluded from analysis. Subjects in the transperineal arm that underwent a transrectal biopsy or withdrew were excluded from analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transrectal', 'description': 'Patients will receive a transrectal MRI-guided prostate biopsy.\n\nTransrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.\n\nAntibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).\n\nNo antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.'}, {'id': 'FG001', 'title': 'Transperineal', 'description': 'Patients will receive a transperineal MRI-guided prostate biopsy.\n\nTransperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '342'}, {'groupId': 'FG001', 'numSubjects': '345'}]}, {'type': 'Intent To Treat (Underwent Non-assigned Intervention)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '282'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '63'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '345', 'groupId': 'BG001'}, {'value': '687', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Transrectal', 'description': 'Patients will receive a transrectal MRI-guided prostate biopsy.\n\nTransrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.\n\nAntibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).\n\nNo antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.'}, {'id': 'BG001', 'title': 'Transperineal', 'description': 'Patients will receive a transperineal MRI-guided prostate biopsy.\n\nTransperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '61', 'upperLimit': '71'}, {'value': '66', 'groupId': 'BG001', 'lowerLimit': '61', 'upperLimit': '71'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '61', 'upperLimit': '71'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '342', 'groupId': 'BG000'}, {'value': '345', 'groupId': 'BG001'}, {'value': '687', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'title': 'Hispanic ethnicity', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '332', 'groupId': 'BG000'}, {'value': '334', 'groupId': 'BG001'}, {'value': '666', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '342', 'groupId': 'BG000'}, {'value': '345', 'groupId': 'BG001'}, {'value': '687', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-24', 'size': 488361, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-27T11:48', 'hasProtocol': True}, {'date': '2021-10-22', 'size': 230007, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-29T16:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Radiologists assessing MRI results are blinded to treatment assignment. Pathologists assessing biopsy results are blinded to treatment assignment.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Men enrolled in this prospective, randomized trial will be randomized in a 1:1 ratio to receive either transperineal MRI-targeted or transrectal MRI-targeted prostate biopsy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 687}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2021-04-10', 'resultsFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2021-04-10', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-14', 'studyFirstPostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects That Experienced Infection, Urinary Retention or Bleeding Requiring Intervention Within 7 Days of Biopsy Based on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ)', 'timeFrame': '7 days post-biopsy', 'description': 'Outcome measure Description Now says: Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ) is a validated biopsy questionnaire that measures adverse events that have occurred due to infection. Patient questionnaires that reported infection complications and duration of symptoms, had their electronic medical records verified to confirm if an infection occurred or not.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patient Reporting Biopsy Pain and Discomfort', 'timeFrame': 'Immediately following biopsy, 7 days post-biopsy', 'description': 'Patient reported pain via a yes/no questionnaire'}, {'measure': 'Change in Patient-reported Anxiety, as Measured on a 0-10 Likert Scale', 'timeFrame': 'Immediately following biopsy', 'description': 'Anxiety will be scored on a 0-10 Likert scale. 0 indicates no anxiety and high scores indicate greater anxiety.'}, {'measure': 'Detection of Clinically Significant Disease as Measured by Gleason Grade Group ≥ 2', 'timeFrame': '7 days post-biopsy', 'description': 'Gleason Grade Group is a prostate cancer grading system released by the International Society of Urological Pathology (ISUP). Grade Group 1 indicates Low/Very Low Risk, Grade Group 2 indicates Intermediate (Favorable) Risk, Grade Group 3 indicates Intermediate (Unfavorable) Risk, and Grade Groups 4 and 5 indicate High/Very High Risk.\n\nProstate cancer grade will be categorized into insignificant (Gleason Grade Group 1) and clinically significant (Grade Group ≥ 2).'}, {'measure': 'Change in Adverse Events, as Measured on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ)', 'timeFrame': '7 days post-biopsy', 'description': 'Transrectal Ultrasound Guided prostate Biopsy Questionnaire (TRUS-BxQ) is a validated biopsy questionnaire that measures adverse events that have occurred, such as hospital re-admissions, aborted procedures due to discomfort, hematuria, urinary retention, hematospermia, and/or hematochezia. Patient questionnaire consists of Yes/No questions about general complications and duration of adverse events.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'prostate biopsy', 'biopsy infection', 'fusion biopsy', 'MRI-targeted biopsy', 'transperineal', 'transrectal'], 'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '41298852', 'type': 'DERIVED', 'citation': 'Driscoll CB, Handa N, Huang MM, Murphy AB, Hu JC, Schaeffer EM. Evaluating PI-RADS lesions and clinically significant prostate cancer in Black and Asian men: a PREVENT randomized clinical trial secondary analysis. Prostate Cancer Prostatic Dis. 2025 Nov 26. doi: 10.1038/s41391-025-01057-5. Online ahead of print.'}, {'pmid': '40630527', 'type': 'DERIVED', 'citation': 'Driscoll C, Handa N, Huang M, Murphy A, Hu J, Schaeffer E. Evaluating PI-RADS lesions and clinically significant prostate cancer in Black and Asian men: a PREVENT randomized clinical trial secondary analysis. Res Sq [Preprint]. 2025 Jul 4:rs.3.rs-6905600. doi: 10.21203/rs.3.rs-6905600/v1.'}]}, 'descriptionModule': {'briefSummary': 'Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.\n\nThis randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy.\n\nThe investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.', 'detailedDescription': 'Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.\n\nHowever, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.\n\nTransperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is performed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.\n\nTransperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.\n\nBeyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.\n\nAlthough transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.\n\nThis multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Male sex\n* Age ≥18 years\n* Men without previous prostate biopsy (first time prostate biopsy)\n* Willingness to sign informed consent and adhere to the study protocol\n\nExclusion Criteria\n\n* Acute prostatitis within the last 6 months\n* PSA \\> 20 ng/mL in men who have previously undergone prostate biopsy\n* Current non-urologic bacterial infection requiring active treatment with antibiotics\n* Unfit to undergo prostate biopsy under local anesthesia\n* Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation\n* Men who have previously undergone prostate biopsy in whom artifact would reduce quality of prostate MRI (extensive orthopedic pelvic metal)\n* Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease) in men who have previously undergone prostate biopsy'}, 'identificationModule': {'nctId': 'NCT04843566', 'acronym': 'PREVENT', 'briefTitle': 'PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Evaluation of Transperineal Biopsy Under Local Anesthesia, a Novel Approach to Decrease Post-Biopsy Infections and Improve Cancer Detection', 'orgStudyIdInfo': {'id': '20-04021956'}, 'secondaryIdInfos': [{'id': '1R01CA241758', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA241758', 'type': 'NIH'}, {'id': '18-02-365-NIH', 'type': 'OTHER', 'domain': 'Biomedical Research Alliance of New York (BRANY)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transrectal', 'description': 'Patients will receive a transrectal MRI-guided prostate biopsy.', 'interventionNames': ['Procedure: Transrectal MRI-guided prostate biopsy', 'Drug: Antibiotic (prophylaxis)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transperineal', 'description': 'Patients will receive a transperineal MRI-guided prostate biopsy.', 'interventionNames': ['Procedure: Transperineal MRI-guided prostate biopsy']}], 'interventions': [{'name': 'Transperineal MRI-guided prostate biopsy', 'type': 'PROCEDURE', 'description': 'Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.', 'armGroupLabels': ['Transperineal']}, {'name': 'Transrectal MRI-guided prostate biopsy', 'type': 'PROCEDURE', 'description': 'Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.', 'armGroupLabels': ['Transrectal']}, {'name': 'Antibiotic (prophylaxis)', 'type': 'DRUG', 'description': 'For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).\n\nNo antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.', 'armGroupLabels': ['Transrectal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109-5624', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical School', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '11217', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork Presbyterian Brooklyn Methodist Hospital', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11355', 'city': 'Flushing', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork-Presbyterian Queens', 'geoPoint': {'lat': 40.76538, 'lon': -73.81736}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Jim C Hu, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Cornell Medicine, NewYork-Presbyterian'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}