Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-06 @ 2:56 AM
Study NCT ID:
NCT03284151
Status:
UNKNOWN
Last Update Posted:
2022-06-22
First Post:
2017-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma
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': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-20', 'studyFirstSubmitDate': '2017-09-07', 'studyFirstSubmitQcDate': '2017-09-14', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delay between the initial diagnosis and date of salvage treatment', 'timeFrame': 'through study completion, up to 36 months', 'description': 'Delay between the initial diagnosis and date of salvage treatment'}], 'secondaryOutcomes': [{'measure': 'PSA evaluation', 'timeFrame': '3, 6, 12, 18, 24, 30, 36 months', 'description': 'PSA dosage'}, {'measure': 'Birads score evaluation', 'timeFrame': '12, 24, 36 months', 'description': 'Multiparametric prostatic MRI'}, {'measure': 'Acute and late toxicity', 'timeFrame': '3, 6, 12, 18, 24, 30, 36 months', 'description': 'Acute and late toxicity using the CTCAEv4'}, {'measure': 'IPSS evaluation', 'timeFrame': '12, 24, 36 months', 'description': 'IPSS score'}, {'measure': 'IIEF5 evaluation', 'timeFrame': '12, 24, 36 months', 'description': 'IIEF5 score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prostate cancer', 'good prognosis', 'focused treatment', 'Cyberknife'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.', 'detailedDescription': 'Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.\n\nSecond objectives : objectives: prostate-specific antigen (PSA) response, MRI response, toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The International Index of Erectile Function (IIEF5) scores).\n\nMethod At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the whole gland.\n\nPlacement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced.\n\nTreatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days. Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35\\<2cc. Bladder neck and urethra: V35\\<1cc.\n\nSalvage treatments: in such a context, salvage surgery or salvage intensity modulation radiation therapy (IMRT) treatments can in theory remain valid and safe options.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prostatic adenocarcinoma Capra≤2', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prostatic adenocarcinoma of Capra score≤2 invading no more than two adjacent of the 12 prostatic zones. Lesions\\>3mm. Maximal urinary flow rate ≥ 10ml/s, mean flow rate ≥ 5ml/s, post micturation volume ≤80ml, IPSS score ≤15.\n\nExclusion Criteria:\n\n* systemic disease, ulcerative hemorrhagic ulcer or Crohn diseases, bladder neck stenosis, urethral implants, transurethral prostatectomy (TURP), any recurrent prostatitis within the last 3 years.'}, 'identificationModule': {'nctId': 'NCT03284151', 'briefTitle': 'Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse, Luxembourg'}, 'officialTitle': 'Robotic and Focused Stereotactic Radiation Treatment of Good Prognosis Prostatic Adenocarcinoma', 'orgStudyIdInfo': {'id': 'CYM6 Prostate CFB2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cyberknife', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4005', 'city': 'Esch-sur-Alzette', 'country': 'Luxembourg', 'facility': 'Centre Francois Baclesse', 'geoPoint': {'lat': 49.49583, 'lon': 5.98056}}], 'overallOfficials': [{'name': 'Philippe Nickers, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre Francois Baclesse'}, {'name': 'Michel Untereiner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Francois Baclesse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse, Luxembourg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}