Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-26 @ 12:45 AM
Study NCT ID:
NCT04607135
Status:
TERMINATED
Last Update Posted:
2025-05-06
First Post:
2020-10-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ARFI Imaging for Targeted Prostate Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}}}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054459', 'term': 'Elasticity Imaging Techniques'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kathy.nightingale@duke.edu', 'phone': '919-660-5175', 'title': 'Kathy Nightingale, Ph.D.', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 mins', 'description': 'Each participant was to undergo all three types of biopsy.', 'eventGroups': [{'id': 'EG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling is a probability sampling method in which a random sample, with a fixed periodic interval, is selected from a larger population.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 minutes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were imaged with that biopsy approach and in whom cancer of any grade was detected by any biopsy approach. All but one participant underwent all three types of biopsy. One subject did not undergo MR-ultrasound fusion biopsy, but did complete the other two procedures.'}, {'type': 'PRIMARY', 'title': 'Length of Cancerous Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '3.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'F-statistic = 11.71', 'statisticalMethod': "Welch's ANOVA", 'nonInferiorityType': 'OTHER'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'q-statistic = 6.74', 'statisticalMethod': 'Games-Howell post-hoc test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'q-statistic = 2.34', 'statisticalMethod': 'Games-Howell post-hoc test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.35', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'q-statistic = 2.04', 'statisticalMethod': 'Games-Howell post-hoc test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 minutes', 'description': 'Length of carcinoma per cancer-positive biopsy specimen as reported by the pathology findings, computed from all cancer-positive biopsy specimens from a given biopsy approach for each participant in whom cancer of any grade was detected by any biopsy approach.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in whom cancer was detected by a given biopsy approach.'}, {'type': 'PRIMARY', 'title': 'Grade Group of Cancerous Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.92', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '1.86', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '1.96', 'spread': '1.15', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk. For each subject, the highest grade group detected by a given biopsy approach is assigned to that subject for that biopsy approach.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in whom cancer was detected by a given biopsy approach.'}, {'type': 'PRIMARY', 'title': 'Gleason Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.62', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '6.77', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '6.74', 'spread': '0.81', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 minutes', 'description': 'A commonly used method to classify how cells appear in cancerous tissues; the less the cancerous cells look like normal cells, the more malignant the cancer; two numbers, each from 1 to 5, are assigned to the two most predominant types of cells present. These two numbers are added together to produce the Gleason score with a total range of 2 to 10. Higher numbers indicate more aggressive cancers. For each subject, the highest Gleason score detected by a given biopsy approach is assigned to that subject for that biopsy approach.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in whom cancer was detected by each biopsy approach.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade Group 1 Cancer, In Whom Cancer Was Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in whom Grade Group 1 was the highest grade of cancer that was detected by any biopsy approach.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade Group 2 Cancer, In Whom Cancer (of Any Grade) Was Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in whom Grade Group 2 was the highest grade of cancer that was detected by any biopsy approach.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade Group 2 Cancer, Graded as Grade Group 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in whom Grade Group 2 was the highest grade of cancer that was detected by any biopsy approach.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade Group 3 Cancer, In Whom Cancer (of Any Grade) Was Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were imaged with that biopsy approach and in whom Grade Group 3 was the highest grade of cancer that was detected by any biopsy approach.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade Group 3 Cancer, Graded as Grade Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were imaged with that biopsy approach and in whom Grade Group 3 was the highest grade of cancer that was detected by any biopsy approach.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade Group 4 Cancer, In Whom Cancer (of Any Grade) Was Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in whom Grade Group 4 was the highest grade of cancer that was detected by any biopsy approach.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade Group 4 Cancer, Graded as Grade Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in whom Grade Group 4 was the highest grade of cancer that was detected by any biopsy approach.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade Group 5 Cancer, In Whom Cancer (of Any Grade) Was Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in whom Grade Group 5 was the highest grade of cancer that was detected by any biopsy approach.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade Group 5 Cancer, Graded as Grade Group 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acoustic Radiation Force Impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nAcoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.'}, {'id': 'OG001', 'title': 'MR-ultrasound Fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.'}, {'id': 'OG002', 'title': 'Systematic Sampling', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in whom Grade Group 5 was the highest grade of cancer that was detected by any biopsy approach.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Suspected PCa Who Are Scheduled to Undergo an Ultrasound Fusion-MR Prostate Biopsy', 'description': 'Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'Acoustic Radiation Force Impulse (ARFI)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'MR-ultrasound Fusion', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'Systematic Sampling', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Equipment not working', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment for this study took place from October 2021 to March 2023.', 'preAssignmentDetails': 'Record and results are representative of Part 2 of the protocol. The results of Part 1 were not intended to be reported with Part 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Suspected PCa Who Are Scheduled to Undergo an Ultrasound Fusion-MR Prostate Biopsy', 'description': 'Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.\n\nUltrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.\n\nSystematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '6.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-18', 'size': 72438, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-14T13:28', 'hasProtocol': True}, {'date': '2022-08-18', 'size': 198261, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-20T14:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'Current sample size sufficiently powers the study to evaluate outcome measures', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2020-10-22', 'resultsFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2020-10-22', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-04', 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade', 'timeFrame': 'Up to 30 minutes'}, {'measure': 'Length of Cancerous Tissue', 'timeFrame': 'Up to 30 minutes', 'description': 'Length of carcinoma per cancer-positive biopsy specimen as reported by the pathology findings, computed from all cancer-positive biopsy specimens from a given biopsy approach for each participant in whom cancer of any grade was detected by any biopsy approach.'}, {'measure': 'Grade Group of Cancerous Tissue', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk. For each subject, the highest grade group detected by a given biopsy approach is assigned to that subject for that biopsy approach.'}, {'measure': 'Gleason Score', 'timeFrame': 'Up to 30 minutes', 'description': 'A commonly used method to classify how cells appear in cancerous tissues; the less the cancerous cells look like normal cells, the more malignant the cancer; two numbers, each from 1 to 5, are assigned to the two most predominant types of cells present. These two numbers are added together to produce the Gleason score with a total range of 2 to 10. Higher numbers indicate more aggressive cancers. For each subject, the highest Gleason score detected by a given biopsy approach is assigned to that subject for that biopsy approach.'}, {'measure': 'Number of Participants With Grade Group 1 Cancer, In Whom Cancer Was Detected', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.'}, {'measure': 'Number of Participants With Grade Group 2 Cancer, In Whom Cancer (of Any Grade) Was Detected', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.'}, {'measure': 'Number of Participants With Grade Group 2 Cancer, Graded as Grade Group 2', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.'}, {'measure': 'Number of Participants With Grade Group 3 Cancer, In Whom Cancer (of Any Grade) Was Detected', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.'}, {'measure': 'Number of Participants With Grade Group 3 Cancer, Graded as Grade Group 3', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.'}, {'measure': 'Number of Participants With Grade Group 4 Cancer, In Whom Cancer (of Any Grade) Was Detected', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.'}, {'measure': 'Number of Participants With Grade Group 4 Cancer, Graded as Grade Group 4', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.'}, {'measure': 'Number of Participants With Grade Group 5 Cancer, In Whom Cancer (of Any Grade) Was Detected', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.'}, {'measure': 'Number of Participants With Grade Group 5 Cancer, Graded as Grade Group 5', 'timeFrame': 'Up to 30 minutes', 'description': 'The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transrectal Ultrasound', 'Prostate biopsy'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Chan DY. A 3-D Multiparametric Ultrasound Elasticity Imaging System for Targeted Prostate Biopsy Guidance [dissertation]. Durham (NC): Duke University; 2023.'}, {'pmid': '39760302', 'type': 'RESULT', 'citation': 'Chan DY, Moavenzadeh SR, Wightman WE, Palmeri ML, Polascik TJ, Nightingale KR. Clinical Feasibility of 3-D Acoustic Radiation Force Impulse (ARFI) Imaging for Targeted Prostate Biopsy Guidance. Ultrason Imaging. 2025 Mar;47(2):79-92. doi: 10.1177/01617346241311901. Epub 2025 Jan 6.'}, {'pmid': '40270056', 'type': 'RESULT', 'citation': 'Moavenzadeh SR, Chan DY, Adams ES, Deivasigamani S, Kotamarti S, Palmeri ML, Polascik TJ, Nightingale KR. Evaluation of 3D ARFI imaging of prostate cancer: diagnostic reliability and concordance with MpMRI. Cancer Imaging. 2025 Apr 23;25(1):55. doi: 10.1186/s40644-025-00874-0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a new ultrasound technique. This technique may provide additional and improved information about the stiffness and sizes of the internal structures of your prostate in order to improve the guidance for a targeted biopsy. The investigational, custom-designed probe and needle guide will be used to produce images of your prostate and provide guidance for up to 4 additional biopsy samples (cores) prior to a standard magnetic resonance (MR) ultrasound fusion biopsy procedure. Above the time required for the MR ultrasound fusion biopsy, this study will take up to 30 additional minutes of time for collection of the investigational device guided collection of biopsy samples Risks of participation include increased time under anesthesia (to collect additional biopsies) and slight heating of tissue.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men who are scheduled to undergo ultrasound fusion-MR prostate biopsy;\n* Men who are willing to participate in the study;\n* Subjects must freely sign informed consent to enroll in the study;\n* Assessing eligibility: eligibility for the study will be assessed, based upon the above criteria, by the participating urologist at the time of consultation.\n* 18 years or older\n\nExclusion Criteria:\n\n* Men who have had previous treatment for PCa including radiation, cryoablation, chemotherapy, surgery, high intensity focused ultrasound (HIFU), laser therapy or hormone therapy;\n* Men who have had previous non-pharmacological invasive or minimally invasive treatment for benign prostatic hypertrophy (BPH) (i.e., TURP, TUMPT, WIT, TUNA, etc);\n* standard pharmacological treatment of BPH is allowable\n* Men who are mentally impaired and cannot give written consent;\n* Men with anomalies of the rectum.'}, 'identificationModule': {'nctId': 'NCT04607135', 'briefTitle': 'ARFI Imaging for Targeted Prostate Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Acoustic Radiation Force Impulse (ARFI) Imaging for Targeted Prostate Biopsy', 'orgStudyIdInfo': {'id': 'Pro00106093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acoustic radiation force impulse (ARFI)', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.', 'interventionNames': ['Device: Acoustic radiation force impulse (ARFI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MR-ultrasound fusion', 'description': 'Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.', 'interventionNames': ['Device: Ultrasound']}], 'interventions': [{'name': 'Acoustic radiation force impulse (ARFI)', 'type': 'DEVICE', 'description': 'Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system', 'armGroupLabels': ['Acoustic radiation force impulse (ARFI)']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen', 'armGroupLabels': ['MR-ultrasound fusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Thomas Polascik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Kathryn Nightingale, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}