Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-04 @ 8:52 PM
Study NCT ID:
NCT02279693
Status:
TERMINATED
Last Update Posted:
2024-02-14
First Post:
2014-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Dose Received by the Prostate With in Vivo Dosimetry in Patients Treated With Daily IGRT Associated With IMRT Using Two Repositioning Techniques for Localized Prostate Cancer
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': 'D057918', 'term': 'Fiducial Markers'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D012015', 'term': 'Reference Standards'}, {'id': 'D014894', 'term': 'Weights and Measures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'feasibility problem', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2014-10-28', 'studyFirstSubmitQcDate': '2014-10-30', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Raypilot dosimetry', 'CBCT (cone beam computed tomography)'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study evaluates the dose received by the prostate with in vivo dosimetry when delivering image guided radiation therapy (IGRT) associated with intensity modulated radiation therapy (IMRT) for patients with localized prostate cancer using two repositioning techniques: fiduciary markers or soft tissues.', 'detailedDescription': '10 participants will receive a cone beam computed tomography (CBCT) repositioning, while the other 10 will receive a kV imaging of fiducial marker repositioning. The principal objective is to evaluate and compare the dose received by the prostate using two repositioning techniques.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male \\> 18 years\n* carcinoma of the prostate histologically confirmed\n* OMS 0-1\n* localized stage\n* favorable, intermediate and unfavorable groups according to NCCN or D'Amico classification\n* patients must have signed a written informed consent form\n* patients must be affiliated to a Social Health Insurance.\n\nExclusion Criteria:\n\n* metastasis\n* indication for pelvic radiation\n* anticoagulant therapy\n* lateral or bilateral hip replacement\n* patient receiving an adult protective services\n* Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons"}, 'identificationModule': {'nctId': 'NCT02279693', 'acronym': 'PROSTRACK', 'briefTitle': 'Evaluation of the Dose Received by the Prostate With in Vivo Dosimetry in Patients Treated With Daily IGRT Associated With IMRT Using Two Repositioning Techniques for Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Georges Francois Leclerc'}, 'orgStudyIdInfo': {'id': '2014-A00122-45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CBCT', 'description': 'cone beam computed tomography (CBCT) repositioning', 'interventionNames': ['Other: CBCT', 'Radiation: IGRT Associated With IMRT']}, {'type': 'OTHER', 'label': 'fiducial markers', 'description': 'kV imaging of fiducial marker repositioning', 'interventionNames': ['Other: fiducial marker (kV imaging)', 'Radiation: IGRT Associated With IMRT']}], 'interventions': [{'name': 'CBCT', 'type': 'OTHER', 'description': '10 participants will receive a cone beam computed tomography (CBCT) repositioning', 'armGroupLabels': ['CBCT']}, {'name': 'fiducial marker (kV imaging)', 'type': 'OTHER', 'description': '10 participants will receive a kV imaging of fiducial marker repositioning.', 'armGroupLabels': ['fiducial markers']}, {'name': 'IGRT Associated With IMRT', 'type': 'RADIATION', 'armGroupLabels': ['CBCT', 'fiducial markers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges-François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'overallOfficials': [{'name': 'Gilles CREHANGE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Georges François Leclerc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Georges Francois Leclerc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}