Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-27 @ 1:19 PM
Study NCT ID:
NCT00635167
Status:
TERMINATED
Last Update Posted:
2025-05-16
First Post:
2008-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'edouard.trabulsi@jefferson.edu', 'phone': '215-955-1000', 'title': 'Dr. Edouard Trabulsi', 'organization': 'Sidney Kimmel Cancer Center at Thomas Jefferson University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Contrast Enhanced Transrectal Ultrasound (TRUS)', 'description': 'Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \\[Visit 2\\]); week 5 (middle of treatment \\[Visit 3\\]); week 10 (end of treatment \\[Visit 4\\]); week 18 (2 months after end of EBRT \\[Visit 5\\]); week 26 (4 months after end of EBRT \\[Visit 6\\]); and week 36 (6 months after end of EBRT \\[Visit 7\\]).', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Contrast Enhanced Transrectal Ultrasound (TRUS)', 'description': 'Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \\[Visit 2\\]); week 5 (middle of treatment \\[Visit 3\\]); week 10 (end of treatment \\[Visit 4\\]); week 18 (2 months after end of EBRT \\[Visit 5\\]); week 26 (4 months after end of EBRT \\[Visit 6\\]); and week 36 (6 months after end of EBRT \\[Visit 7\\]).'}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.'}, {'type': 'SECONDARY', 'title': 'Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Contrast Enhanced Transrectal Ultrasound (TRUS)', 'description': 'Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \\[Visit 2\\]); week 5 (middle of treatment \\[Visit 3\\]); week 10 (end of treatment \\[Visit 4\\]); week 18 (2 months after end of EBRT \\[Visit 5\\]); week 26 (4 months after end of EBRT \\[Visit 6\\]); and week 36 (6 months after end of EBRT \\[Visit 7\\]).'}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.'}, {'type': 'SECONDARY', 'title': 'Patient Tolerance of TRUS Evaluation During/After Radiation Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Contrast Enhanced Transrectal Ultrasound (TRUS)', 'description': 'Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \\[Visit 2\\]); week 5 (middle of treatment \\[Visit 3\\]); week 10 (end of treatment \\[Visit 4\\]); week 18 (2 months after end of EBRT \\[Visit 5\\]); week 26 (4 months after end of EBRT \\[Visit 6\\]); and week 36 (6 months after end of EBRT \\[Visit 7\\]).'}], 'timeFrame': '1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Contrast Enhanced Transrectal Ultrasound (TRUS)', 'description': 'Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \\[Visit 2\\]); week 5 (middle of treatment \\[Visit 3\\]); week 10 (end of treatment \\[Visit 4\\]); week 18 (2 months after end of EBRT \\[Visit 5\\]); week 26 (4 months after end of EBRT \\[Visit 6\\]); and week 36 (6 months after end of EBRT \\[Visit 7\\]).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Contrast Enhanced Transrectal Ultrasound (TRUS)', 'description': 'Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \\[Visit 2\\]); week 5 (middle of treatment \\[Visit 3\\]); week 10 (end of treatment \\[Visit 4\\]); week 18 (2 months after end of EBRT \\[Visit 5\\]); week 26 (4 months after end of EBRT \\[Visit 6\\]); and week 36 (6 months after end of EBRT \\[Visit 7\\]).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Closed by PI final report submitted', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2011-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2008-03-05', 'resultsFirstSubmitDate': '2018-07-13', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-13', 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurable Decrease in Prostate Vascularity During and/or After Radiation Treatment', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Sonographic Appearance of Prostate and Prostate Vascularity Before, During and After External Beam Radiotherapy (Standard of Care) for Prostate Cancer', 'timeFrame': '1 year'}, {'measure': 'Patient Tolerance of TRUS Evaluation During/After Radiation Treatment', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate cancer', 'prostatic vascularity', 'External Beam Radiation treatment', 'Contrast Enhanced transrectal Ultrasound'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '12354987', 'type': 'BACKGROUND', 'citation': "Halpern EJ, Frauscher F, Strup SE, Nazarian LN, O'Kane P, Gomella LG. Prostate: high-frequency Doppler US imaging for cancer detection. Radiology. 2002 Oct;225(1):71-7. doi: 10.1148/radiol.2251011938."}, {'pmid': '11906872', 'type': 'BACKGROUND', 'citation': 'Halpern EJ, Frauscher F, Rosenberg M, Gomella LG. Directed biopsy during contrast-enhanced sonography of the prostate. AJR Am J Roentgenol. 2002 Apr;178(4):915-9. doi: 10.2214/ajr.178.4.1780915.'}, {'pmid': '18158034', 'type': 'BACKGROUND', 'citation': 'Nelson ED, Slotoroff CB, Gomella LG, Halpern EJ. Targeted biopsy of the prostate: the impact of color Doppler imaging and elastography on prostate cancer detection and Gleason score. Urology. 2007 Dec;70(6):1136-40. doi: 10.1016/j.urology.2007.07.067.'}, {'pmid': '17874649', 'type': 'BACKGROUND', 'citation': 'Linden RA, Halpern EJ. Advances in transrectal ultrasound imaging of the prostate. Semin Ultrasound CT MR. 2007 Aug;28(4):249-57. doi: 10.1053/j.sult.2007.05.002.'}], 'seeAlsoLinks': [{'url': 'http://hospitals.jefferson.edu/', 'label': 'Thomas Jefferson University Hospital'}]}, 'descriptionModule': {'briefSummary': "Solid tumors, including prostate cancer, commonly exhibit tumor-associated neovascularity (growth of new blood vessels to feed the tumor) with increased microvessel density. Systemic, hormonal, and radiotherapy treatments typically decrease or suppress tumor - associated vascularity through several mechanisms, including apoptosis (process of cell death) and anti-angiogenic pathways (ways to destroy new blood vessel growth). Previously at the investigators' center, they have demonstrated that increased prostatic vascularity (blood vessels defined to prostate) detected ultrasonographically correlated with disease free survival after radical prostatectomy (surgical removal of entire prostate), and may be indicative of higher grade, higher stage disease. The significance of prostate neovascularity in response to treatment with external beam radiotherapy (EBRT) (standard of care) has not been well studied. The investigators hypothesize that prostate cancer that recurs after radiotherapy may exhibit measurable patterns of tumor-associated vascularity, which may represent a minimally invasive marker of cancer stage, grade and response to treatment. The investigators propose a pilot study to assess the feasibility of serial enhanced transrectal ultrasonography (TRUS) examinations during and after radiotherapy for prostate cancer."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged 40 - 80 years old\n* Biopsy proven intermediate/high risk clinically localized prostate cancer, as determined by a Gleason score of 7 or higher, clinical stage T2b or higher, or PSA \\> 10. Pathology will be confirmed by at least two reviews\n* Patients opting for EBRT (external beam radiation therapy, standard of care) without hormonal ablation\n* Ability to undergo serial TRUS procedures\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Subject has known hypersensitivity to octafluoropropane.\n* Evidence of distant metastatic disease on staging evaluation\n* Previous treatment for prostate cancer, including any form of androgen ablation\n* Previous procedures involving the anus or rectum, making serial TRUS difficult or dangerous\n* Expected life expectancy less than 10 years\n* Baseline testosterone \\< 200 ng/dL\n* Subject with cardiac shunts and elevated pulmonary hypertension\n* Subject has worsening or clinically unstable congestive heart failure.\n* Subject has acute myocardial infarction or acute coronary syndrome.\n* Subject has ventricular arrhythmias or is high risk for arrhythmias.\n* Subject has respiratory failure, severe emphysema or pulmonary emboli.\n* Subject has a history of cardiac shunt or pulmonary hypertension.'}, 'identificationModule': {'nctId': 'NCT00635167', 'briefTitle': 'Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Contrast Enhanced Transrectal Ultrasound (TRUS) to Assess Prostatic Vascularity as a Measure of Treatment Response and Early Prediction of Treatment Failure After XRT', 'orgStudyIdInfo': {'id': '07D.218'}, 'secondaryIdInfos': [{'id': 'JT 1259', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Contrast Enhanced Transrectal Ultrasound (TRUS)', 'interventionNames': ['Drug: Contrast Enhanced-Transrectal Ultrasound']}], 'interventions': [{'name': 'Contrast Enhanced-Transrectal Ultrasound', 'type': 'DRUG', 'description': 'Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \\[Visit 2\\]); week 5 (middle of treatment \\[Visit 3\\]); week 10 (end of treatment \\[Visit 4\\]); week 18 (2 months after end of EBRT \\[Visit 5\\]); week 26 (4 months after end of EBRT \\[Visit 6\\]); and week 36 (6 months after end of EBRT \\[Visit 7\\]).', 'armGroupLabels': ['Contrast Enhanced Transrectal Ultrasound (TRUS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Edouard J Trabulsi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}