Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT07075705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transperineal Micro-ultrasound for the Detection of Prostate Cancer During 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-07-09', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with Prostate Risk Identification Using Micro-Ultrasound (PRIMUS) score (Feasibility)', 'timeFrame': 'Up to 2 months', 'description': 'At the first stage, 28 patients will be enrolled. If the procedure was successful in at least 18 patients, the procedure will be considered feasible, and the study will proceed to the next stage. If less than 18 successes were observed, the study team will determine whether to continue the trial based on the data collected.'}, {'measure': 'Visualization of the prostate from base to apex with adequate image quality for PRIMUS scoring', 'timeFrame': 'Up to 2 months', 'description': 'Will decide yes or no for whether the prostate can be assessed using transperineal micro ultrasound in order to evaluate for possible prostate cancer using the PRIMUS scoring system. This includes being able to visualize the prostate from base to apex with adequate image quality for PRIMUS scoring.'}, {'measure': 'Visualization of the prostate from right and left lateral margins with adequate image quality for PRIMUS scoring', 'timeFrame': 'Up to 2 months', 'description': 'Will decide yes or no for whether the prostate can be assessed using transperineal micro ultrasound in order to evaluate for possible prostate cancer using the PRIMUS scoring system. This includes being able to visualize the prostate from right and left lateral margins with adequate image quality for PRIMUS scoring.'}], 'secondaryOutcomes': [{'measure': 'Successful generation of PRIMUS score in transperineal and transrectal ultrasound images', 'timeFrame': 'Up to 7 months', 'description': 'Will compare transrectal and transperineal micro-ultrasound assessment of PRIMUS score. This will be a yes/no comparison. Summary statistics in frequencies and relative frequencies will be provided.'}, {'measure': 'Ability to visualize the whole prostate using transperineal micro-ultrasound', 'timeFrame': 'Up to 7 months', 'description': 'This will be a yes/no comparison. Summary statistics in frequencies and relative frequencies will be provided.'}, {'measure': 'Quality of images of transperineal ultrasound and transrectal ultrasound of the prostate', 'timeFrame': 'Up to 7 months', 'description': 'The quality of images of transperineal ultrasound will be compared to transrectal ultrasound of the prostate. Summary statistics in frequencies and relative frequencies will be provided.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Carcinoma']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies whether transperineal micro-ultrasound can be used to detect prostate cancer during biopsy. Transrectal ultrasound is often used during prostate biopsy. Transrectal ultrasound imaging is a procedure in which a probe that sends out high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissue called a sonogram. Transrectal ultrasound is used to look for abnormalities in the rectum and nearby structures, including the prostate. The images are used to guide the prostate biopsy. Transperineal micro-ultrasound is completed by placing a probe over the skin between the scrotum and anus (perineum). It is a high-resolution ultrasound at 29 megahertz (MHz) (compared to traditional ultrasound at 6-9 MHz). This higher frequency allows for an improved spatial resolution. This improved spatial resolution is approximately the diameter of a prostatic duct, and therefore, may be able to visualize slight changes in the structure of prostatic ducts that are not possible with standard transrectal ultrasound. Transperineal micro-ultrasound may be more effective in detecting prostate cancer during biopsy.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To investigate the feasibility and validity of using transperineal micro-ultrasound to image the prostate and detect clinically significant prostate cancer.\n\nII. To test the quality of visualization of the prostate gland using micro-ultrasound via the transperineal approach.\n\nSECONDARY OBJECTIVE:\n\nI. To compare micro-ultrasound images done via the transperineal method to micro-ultrasound images done via the transrectal method to see if transperineal ultrasound has similar ability to detect suspicious prostate lesions as transrectal micro-ultrasound.\n\nOUTLINE:\n\nPatients undergo transperineal micro-ultrasound imaging over 3 minutes followed by transrectal micro-ultrasound imaging during standard of care prostate biopsy. Patients also undergo magnetic resonance imaging (MRI) during screening.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men aged ≥ 18 years\n* Men scheduled for transrectal ultrasound guided prostate biopsy who have had a prebiopsy MRI. Therefore patients unable to have a prebiopsy MRI who have contraindications to MRI or unwilling to undergo MRI would be excluded\n* The participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form before receiving any study-related procedure\n\nExclusion Criteria:\n\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate for study participation"}, 'identificationModule': {'nctId': 'NCT07075705', 'briefTitle': 'Transperineal Micro-ultrasound for the Detection of Prostate Cancer During Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Investigating the Feasibility of Using Transperineal Micro-Ultrasound to Detect Clinically Significant Prostate Cancer', 'orgStudyIdInfo': {'id': 'I-4290824'}, 'secondaryIdInfos': [{'id': 'NCI-2025-04490', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I-4290824', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (transperineal micro-ultrasound)', 'description': 'Patients undergo transperineal micro-ultrasound imaging over 3 minutes followed by transrectal micro-ultrasound imaging during standard of care prostate biopsy. Patients also undergo MRI during screening.', 'interventionNames': ['Procedure: Biopsy of Prostate', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Micro-ultrasound Imaging']}], 'interventions': [{'name': 'Biopsy of Prostate', 'type': 'PROCEDURE', 'otherNames': ['Prostate Biopsy', 'Prostatic Biopsy'], 'description': 'Undergo standard of care prostate biopsy', 'armGroupLabels': ['Diagnostic (transperineal micro-ultrasound)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging (MRI)', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'MRIs', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging', 'sMRI', 'Structural MRI'], 'description': 'Undergo MRI', 'armGroupLabels': ['Diagnostic (transperineal micro-ultrasound)']}, {'name': 'Micro-ultrasound Imaging', 'type': 'PROCEDURE', 'otherNames': ['Micro ultrasound', 'Micro ultrasound Imaging', 'Micro-ultrasound', 'microUS'], 'description': 'Undergo transperineal micro-ultrasound imaging', 'armGroupLabels': ['Diagnostic (transperineal micro-ultrasound)']}, {'name': 'Micro-ultrasound Imaging', 'type': 'PROCEDURE', 'otherNames': ['Micro ultrasound', 'Micro ultrasound Imaging', 'Micro-ultrasound', 'microUS'], 'description': 'Undergo transrectal micro-ultrasound imaging', 'armGroupLabels': ['Diagnostic (transperineal micro-ultrasound)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Khurshid A. Guru', 'role': 'CONTACT', 'email': 'Khurshid.guru@roswellpark.org', 'phone': '716-845-6844'}, {'name': 'Khurshid A. Guru', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Khurshid A Guru', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}