Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2026-02-08 @ 8:37 AM
Study NCT ID:
NCT03734757
Status:
UNKNOWN
Last Update Posted:
2020-07-30
First Post:
2018-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk 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': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2018-10-31', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delineation volumes', 'timeFrame': '1 day', 'description': 'Measure of volumes delineation for radiotherapy thanks to trimodality and comparison to those obtained with standard technique'}], 'secondaryOutcomes': [{'measure': 'Treatment plan', 'timeFrame': '6 weeks', 'description': 'percentage of patient for whom the therapeutic decision will be different with standard assessment'}, {'measure': 'Dosimetry', 'timeFrame': '6 weeks', 'description': 'Variation of dosimetry between trimodality imaging and standard assessment'}, {'measure': 'F-choline fixation in MRI', 'timeFrame': '1 day', 'description': 'Comparison of percentage of choline fixation during magnetic resonance imaging'}, {'measure': 'contouring of target lesions and organ at risk', 'timeFrame': '6 weeks', 'description': 'comparison of contouring duration with the two techniques of imagery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'Imaging', 'trimodality'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The initial staging of locally advanced prostate cancer is made with Computed Tomography scan (CT), Magnetic Resonance Imaging (MRI), and bone scan (BS).\n\nFor this type of cancer, reference treatment is radiotherapy combined with hormone therapy.\n\nThe added value of MRI in the delineation of volumes for radiotherapy is known, especially for the definition of extra-prostatic extensions and prostatic apex. However, its regular use is difficult. Indeed, acquisition of Magnetic Resonance Imaging parameters for diagnostic are not adapted to be fused with the planning Computed Tomography.\n\nThe literature shows that Positron Emission Tomography-Computed Tomography with Fluorocholine is better in terms of diagnostic performance compared to bone scan for bone metastases and to pelvic Magnetic Resonance Imaging for nodal extension.\n\nIt would therefore improve staging for these patients with a high risk of locoregional and metastatic invasion even if its use is currently not recommended in the initial staging.\n\nThanks to Magnetic Resonance Imaging acquisition parameters adapted to Radiotherapy and additional functional information, an acquisition in tri-modality Positron Emission Tomography/computed Tomography/ Magnetic Resonance Imaging could have an impact on the volumes definition for radiotherapy or even on the therapeutic strategy.\n\nThe aim of the study is to evaluate the volume modifications obtained on the trimodality evaluation, compared to the standard initial staging (geometric comparison).\n\nIn addition, it would be a preliminary study for a project using Prostate-specific membrane antigen (PSMA) in trimodality, and / or for a therapeutic interventional study.', 'detailedDescription': 'Prostate cancer (Pca) is the first human cancer in terms of incidence and the third leading cause of tumor death (56,000 new cases/year in France in 2012 and nearly 9,000 deaths). According to the French Association of Urology 2013, an individual screening based on rectal examination and prostatic specific antigen (PSA) is recommended for men over 50. Ultrasound (US) guided biopsy allows the histological diagnosis and the Gleason score evaluation. For high-risk of prostate Cancer, initial staging is based on pelvic Magnetic Resonance Imaging, abdominal pelvic computed tomography and bone scan.\n\nExternal radiotherapy combined with prolonged hormone therapy is the reference treatment for these cancers.\n\nRadiotherapy requires a planning Computed Tomography. Magnetic Resonance Imaging is known to be better for definition of extra-prostatic extensions and prostatic apex. However, its regular use is difficult for the radiotherapy planning.\n\nMoreover, Positron Emission Tomography-Computed Tomography with Fluorocholine detects earlier nodal and bone metastasis.\n\nHypothesis: A single planning acquisition in trimodality in radiotherapy position should improve simultaneously the initial staging and the volume delineation for radiotherapy.\n\nMain objective: Main objective is to compare volumes delineation (prostatic target and organ at risk) thanks to geometric index (Jaccard, Dice and overlap), got by trimodality and by standard initial staging and planning Computed Tomography.\n\nExpected results: Thanks to literature data, it can be expected that prostatic delineation target volume will significantly decrease with Magnetic Resonance Imaging.\n\nFurthermore, thanks to Positron Emission Tomography-Computed Tomography with Fluorocholine, radiotherapy planning would be different, detecting 14% of nodal extension and 7% of bone metastasis.\n\nFinally, with trimodality the investigators expect a smaller prostate volume and a higher detection of metastatic lymph node or bone metastasis.\n\nThen, the investigators expect an improvement of the management of patients by:\n\n* Detecting more nodal or bone metastasis and avoiding a useless local treatment by radiotherapy\n* Improving prostatic target volume delineation and allowing a better protection of organ at risk.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* More than 18 years\n* prostate cancer : High risk (according to D'Amico Classification)\n* and/or Node positive on MRI\n* T2c-T3 on MRI\n* with staging assessment\n* will receive radiotherapy\n\nExclusion Criteria:\n\n* second cancer\n* contraindication to MRI\n* participation in an another therapeutic trial\n* patients under guardianship or curatorship"}, 'identificationModule': {'nctId': 'NCT03734757', 'acronym': 'DEMETER', 'briefTitle': 'Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Henri Becquerel'}, 'officialTitle': 'Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer Using Geometric Indexes', 'orgStudyIdInfo': {'id': 'CHB18.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trimodality', 'description': 'PET-CT with fluorocholine and MRI', 'interventionNames': ['Procedure: imaging in trimodality']}], 'interventions': [{'name': 'imaging in trimodality', 'type': 'PROCEDURE', 'description': 'PET-CT and MRI', 'armGroupLabels': ['Trimodality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76038', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Charlotte Bouyeure, MD', 'role': 'CONTACT', 'email': 'anne-charlotte.bouyeure@chb.unicancer.fr', 'phone': '+33232083030'}, {'name': 'Doriane Richard, PhD', 'role': 'CONTACT', 'email': 'doriane.richard@chb.unicancer.fr', 'phone': '+33232082985'}], 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Anne-Charlotte Bouyeure, MD', 'role': 'CONTACT', 'email': 'anne-charlotte.bouyeure@chb.unicancer.fr', 'phone': '+33232083030'}, {'name': 'Doriane Richard, PhD', 'role': 'CONTACT', 'email': 'doriane.richard@chb.unicancer.fr', 'phone': '+33232082985'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Henri Becquerel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}