Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-04 @ 4:50 PM
Study NCT ID:
NCT01148069
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2010-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery Combined With Intensity Modulated Radiation Therapy - Image-Guided Radiation Therapy (IMRT-IGRT) in Locally-advanced Prostate Cancers
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-18', 'studyFirstSubmitDate': '2010-06-18', 'studyFirstSubmitQcDate': '2010-06-18', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of bladder and/or rectal grade ≥2 toxicity (late toxicity)', 'timeFrame': 'between 6 months and 3 years', 'description': 'Rate of bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) observed between 6 months and 3 years after the beginning of the radiotherapy.'}], 'secondaryOutcomes': [{'measure': 'Dose received by the rectum and the bladder with and without seminal vesicles irradiation', 'timeFrame': 'Before treatment', 'description': 'Assessed using a dose-volume histogram'}, {'measure': 'Quality of life', 'timeFrame': '3 years', 'description': 'Assessed with EORTC questionnaires (QLQ-C30, QLQ-PR25)'}, {'measure': 'Erectile troubles', 'timeFrame': '3 years', 'description': 'Assessed with erectile troubles questionnaire (IIEF-5)'}, {'measure': 'Onset of biological signs evocating a recidive', 'timeFrame': '3 years', 'description': 'Assessed with PSA levels'}, {'measure': 'Onset of clinical signs evocating a recidive', 'timeFrame': '3 years'}, {'measure': 'Specific and global survival', 'timeFrame': '3 years'}, {'measure': 'Rate of bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) (early toxicity)', 'timeFrame': '6 months', 'description': 'Rate of late bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) observed 6 months after the beginning of the radiotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IMRT-IGRT', 'radiotherapy toxicity', 'seminal vesicles'], 'conditions': ['Prostate Cancer', 'Prostate Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Standard treatment of locally-advanced prostate cancers consists in the association of radiotherapy of prostate and seminal vesicles (SV) and androgen deprivation (AD) for 3 years. This treatment is usually preceded by pelvic lymphadenectomy to assess the possible extension to lymph nodes of prostatic cancer and to avoid irradiating the pelvis in case of no lymph node involvement. However, radiotherapy leads usually to about 30% of grade ≥2 risk of bladder and/or rectal toxicity. This risk particularly depends on the radiation volume. In the aim of lowering the toxicity, the treatment in this study will associate:\n\n* pelvic lymph node dissection and resection of seminal vesicles, allowing decreasing the radiation target volume to the prostate only (and not to irradiate the SV);\n* a high-precision radiotherapy technique combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).', 'detailedDescription': 'This study targets non metastatic prostatic locally-advanced adenocarcinomas which are at high risk of both local progression and metastases. The standard treatment of these tumours associates external beam radiation therapy (EBRT) and 3 years of androgen deprivation (AD) with LH-RH analogue. In the absence of AD and mainly when prostate specific antigen (PSA) is \\>10 ng/ml, several randomized studies have shown that high doses of EBRT increase biochemical control. Nevertheless, escalating the doses of radiation significantly increases the risk of rectal and/or urinary toxicities. In order to lower the toxicity of irradiation in locally-advanced prostate cancers, and to improve the quality of life of patients, this study aims at decreasing the volume of irradiated healthy tissues. To carry out this objective, we will use a double strategy:\n\n* Limiting the target volume to prostate only by removing seminal vesicles at the time of lymph node dissection,\n* Using a technique of high-precision radiation combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).\n\nBased on the literature, we may assume a toxicity rate of 30% during the three years of hormonotherapy with standard treatment (i.e. without removing seminal vesicles). We make the hypothesis of a 20% absolute reduction of toxicity with our protocol.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18,\n* Prostate adenocarcinoma (histologically proven),\n* Locally-advanced (T3a or Gleason \\> 7 or PSA ≥ 20 ng/mL),\n* Distal half of seminal vesicles unaffected on MRI,\n* Non metastatic cancer: negative extension assessment (on prostatic and pelvic MRI and bone scintigraphy),\n* Radiotherapy and hormonotherapy indication,\n* Medical insurance affiliation,\n* Written informed consent.\n\nNon-inclusion criteria:\n\n* Co-morbidity or medical history contraindicating surgery (pelvic lymphadenectomy and seminal vesicle ablation),\n* Contraindication to pelvic irradiation,\n* Hip prosthesis,\n* History of cancer for the last 5 years (except baso-cellular epithelioma),\n* History of pelvic irradiation,\n* Person deprived of freedom or under guardianship,\n* Participation in another biomedical research.\n\nExclusion Criteria:\n\n* Surgery showing lymph nodes involvement (pelvic radiation indication)\n* Surgery without ablation of seminal vesicles\n* Surgery with positive margins in seminal vesicles'}, 'identificationModule': {'nctId': 'NCT01148069', 'acronym': 'TARGET', 'briefTitle': 'Surgery Combined With Intensity Modulated Radiation Therapy - Image-Guided Radiation Therapy (IMRT-IGRT) in Locally-advanced Prostate Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Surgery Combined With IMRT-IGRT in Locally-advanced Prostate Cancers', 'orgStudyIdInfo': {'id': 'ID RCB 2009-A01336-51'}, 'secondaryIdInfos': [{'id': 'LOC/09-07', 'type': 'OTHER', 'domain': 'Rennes University Hospital'}, {'id': 'CIC0203/128', 'type': 'OTHER', 'domain': 'Rennes Clinical Research Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgery combined with IMRT-IGRT', 'interventionNames': ['Procedure: Surgery combined with IMRT-IGRT']}], 'interventions': [{'name': 'Surgery combined with IMRT-IGRT', 'type': 'PROCEDURE', 'description': 'Patients will have surgery consisting in extensive pelvic dissection and ablation of seminal vesicles. Surgery will be followed by prolonged hormonotherapy (3 years) associated, after 2 months, with prostatic only irradiation.', 'armGroupLabels': ['Surgery combined with IMRT-IGRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': "Service d'Urologie - Hôpital de Pontchaillou", 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugène Marquis - CRLCC', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Renaud DE CREVOISIER, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes CRLCC Eugène Marquis'}, {'name': 'Sebastien VINCENDEAU, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rennes University Hospital'}, {'name': 'Eric BELLISSANT, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center Eugene Marquis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}