Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-12 @ 5:49 AM
Study NCT ID:
NCT02271659
Status:
UNKNOWN
Last Update Posted:
2016-09-13
First Post:
2014-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical and Economic Evaluation for Intermediate-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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 298}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2014-06-02', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the biochemical relapse free survival of the patients in two groups at 5 years for an external beam radiotherapy with a brachytherapy boost versus an exclusive external beam radiotherapy', 'timeFrame': '5 years', 'description': 'Biochemical relapse is defined using the Phoenix definition of nadir of Prostate Specific Antigen + 2 ng/ml. This will be studied for both arms'}], 'secondaryOutcomes': [{'measure': 'The evaluation of the overall survival at 5 years.', 'timeFrame': '5 years', 'description': 'All cause mortality'}, {'measure': 'The evaluation of the specific survival at 5 years', 'timeFrame': '5 years', 'description': 'Mortality due to prostate cancer'}, {'measure': 'The evaluation of the survival without any metastatic evolution at 5 years', 'timeFrame': '5 years'}, {'measure': 'The study of all toxicities', 'timeFrame': '5 years', 'description': 'The toxicities include: acute and late toxicities, sexual toxicities, the quality of life of the patients (CTCAE version 4.0)'}, {'measure': 'Medical and economical evaluation.', 'timeFrame': '5 years', 'description': 'The complete medical and economical evaluation of the strategies'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate', 'external beam radiotherapy', 'brachytherapy boost', 'economical evaluation'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment.\n\nThe study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age between 18 and 80 years;\n* life expectancy of greater than 10 years;\n* prostate adenocarcinoma histologically proven;\n* prostate cancer has to be of intermediate-risk based on at least one of the three following criteria: PSA between 10 ng/ml and 20 ng/ml, and/or a Gleason score of 7 and/or a T2B. Karnofsky performance status ≥ 60% and consequently performance status ECOG 0-2.\n* the patient has to be the beneficiary of the social security system (order n° 2006-477 from April 26th 2006);\n* the signed consent form.\n\nExclusion Criteria:\n\n* PSA level \\> 20;\n* Gleason \\> 7;\n* clinical T3A or T3B or MRI (a simple suspicion/ doubt on the MRI regarding the T3A won't be an exclusion criterion);\n* prostate volume \\> 60 cc;\n* pelvic lymph nodes involvement at dissection or imaging (ADP \\> 1.5 cm);\n* concurrent hormone therapy;\n* the presence of distant metastasis (M1);\n* history of abdominal or pelvic irradiation;\n* history of prostate resection in the previous 6 months and/or not allowing the implantation of markers;\n* history of uncontrolled cancer and/or treated since less than 5 years (excepting the basal-cell carcinoma);\n* urinary discomfort with an IPSS (International Prostate Symptom Score) \\> 15 (without alpha-blocking);\n* inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;\n* other undergoing study that may interfere with the present study;\n* patient under legal protection measure."}, 'identificationModule': {'nctId': 'NCT02271659', 'acronym': 'GETUGP05', 'briefTitle': 'Medical and Economic Evaluation for Intermediate-risk Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Medical and Economic Evaluation of an External Beam Radiotherapy Combined With a Brachytherapy Boost Compared With an Exclusive External Beam Radiotherapy for Intermediate-risk Prostate Cancer', 'orgStudyIdInfo': {'id': '2011-704'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brachytherapy boost', 'description': 'Brachytherapy boost with external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds (110Gy) or high dose rate (14Gy) with iridium-192) only to the prostate. Each center will choose the appropriate brachytherapy technique', 'interventionNames': ['Radiation: Brachytherapy boost with external beam radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exclusive external beam irradiation', 'description': 'Exclusive external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.', 'interventionNames': ['Radiation: Exclusive external beam radiotherapy']}], 'interventions': [{'name': 'Brachytherapy boost with external beam radiotherapy', 'type': 'RADIATION', 'description': "Bras A: External beam radiotherapy of 46 Gy delivered with a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds from Bard (110Gy) or high dose rate (14Gy) with a iridium-192 source) only to the prostate. Each center will choose the appropriate brachytherapy technique. The number of seeds or needles will depend on the prostate's volume.", 'armGroupLabels': ['Brachytherapy boost']}, {'name': 'Exclusive external beam radiotherapy', 'type': 'RADIATION', 'description': 'Bras B: External beam radiotherapy of 46 Gy delivered with photons and a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.', 'armGroupLabels': ['Exclusive external beam irradiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81000', 'city': 'Albi', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent VOTRON, MD', 'role': 'CONTACT', 'email': 'votron@claude-bernard-albi.com', 'phone': '5 63 77 77 50', 'phoneExt': '0033'}], 'facility': 'Clinique Claude Bernard', 'geoPoint': {'lat': 43.9298, 'lon': 2.148}}, {'zip': '25030', 'city': 'Besançon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yasser HAMMOUD, MD', 'role': 'CONTACT', 'email': 'yhammoud@chu-besancon.fr', 'phone': '3 84 46 14 09', 'phoneExt': '0033'}], 'facility': 'CHU Jean MINJOZ', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathalie BONICHON-LAMICHHANE, MD', 'role': 'CONTACT', 'email': 'Bonichon-lamichhane@wanadoo.fr', 'phone': '5 56 39 47 28', 'phoneExt': '0033'}], 'facility': 'Clinique Tivoli', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence THOMAS, MD', 'role': 'CONTACT', 'email': 'Thomas@bergonie.org', 'phone': '5 56 33 33 20', 'phoneExt': '0033'}], 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29609', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Pierre MALHAIRE, MD', 'role': 'CONTACT', 'email': 'jean-pierre.malhaire@chu-brest.fr', 'phone': '2 98 22 37 40', 'phoneExt': '0033'}], 'facility': 'CHRU Morvan', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14076', 'city': 'Caen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marlon SILVA, MD', 'role': 'CONTACT', 'email': 'm.silva@baclesse.unicancer.fr', 'phone': '2 31 45 50 17', 'phoneExt': '0033'}], 'facility': 'Centre Francois Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '21079', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles CREHANGE, MD', 'role': 'CONTACT', 'email': 'gcrehange@dijon.fnclcc.fr', 'phone': '3 80 73 75 18', 'phoneExt': '0033'}], 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38043', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michel BOLLA, MD', 'role': 'CONTACT', 'email': 'mbolla@chu-grenoble.fr', 'phone': '4 76 76 55 06', 'phoneExt': '0033'}], 'facility': 'Hopital de la Tronche', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69373', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascal POMMIER, MD', 'role': 'CONTACT', 'email': 'pommier@lyon.fnclcc.fr', 'phone': '4 78 78 26 52', 'phoneExt': '0033'}], 'facility': 'Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13273', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Naji SALEM, MD', 'role': 'CONTACT', 'email': 'SALEMN@marseille.fnclcc.fr'}], 'facility': 'Institut Paoli Calmette', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '71031', 'city': 'Mâcon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice LORCHEL, MD', 'role': 'CONTACT', 'email': 'lorchel.fabrice@wanadoo.fr', 'phone': '3 85 23 21 00', 'phoneExt': '0033'}], 'facility': "Centre d'oncologie et de radiothérapie Mâcon", 'geoPoint': {'lat': 46.31407, 'lon': 4.82823}}, {'zip': '34298', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Carmen LLACER MOSCARDO, MD', 'role': 'CONTACT', 'email': 'carmen.llacer@valdorel.fnclcc.fr', 'phone': '4 67 61 31 34', 'phoneExt': '0033'}], 'facility': "Centre Val D'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54519', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Didier PEIFFERT, MD', 'role': 'CONTACT', 'email': 'd.peiffert@nancy.fnclcc.fr'}], 'facility': 'Institut de Cancerologie de Lorraine Alexis Vautrin', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '92200', 'city': 'Neuilly-sur-Seine', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent CHAUVEINC, MD', 'role': 'CONTACT', 'email': 'Laurent.chauveinc@free.fr'}], 'facility': 'Clinique Hartmann', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}, {'zip': '06189', 'city': 'Nice', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Michel HANNOUN LEVI, MD', 'role': 'CONTACT', 'email': 'Jean-Michel.HANNOUN-LEVI@nice.fnclcc.fr', 'phone': '4 92 03 12 60', 'phoneExt': '0033'}], 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75248', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alain LABIB, MD', 'role': 'CONTACT', 'email': 'alain.labib@curie.net'}], 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe HENNEQUIN, MD', 'role': 'CONTACT', 'email': 'christophe.hennequin@sls.ap-hop-paris.fr', 'phone': '1 42 49 90 24', 'phoneExt': '0033'}], 'facility': 'Hopital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75908', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Martin HOUSSET, MD', 'role': 'CONTACT', 'email': 'martin.housset@egp.aphp.fr', 'phone': '1 56 09 34 21', 'phoneExt': '0033'}], 'facility': 'Hopital George Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier CHAPET, MD', 'role': 'CONTACT', 'email': 'olivier.chapet@chu-lyon.fr', 'phone': '0033 4 78 86 42 59'}], 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86021', 'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane GUERIF, MD', 'role': 'CONTACT', 'email': 's.guerif@chu-poitiers.fr', 'phone': '5 49 44 44 85', 'phoneExt': '0033'}], 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51056', 'city': 'Reims', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Tan Dat NGUYEN, MD', 'role': 'CONTACT', 'email': 'tandat.nguyen@reims.fnclcc.fr', 'phone': '3 26 50 43 51', 'phoneExt': '0033'}], 'facility': 'Institut Jean Godinot,', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '51057', 'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric MALLET, MD', 'role': 'CONTACT', 'email': 'fmallet@iccreims.fr', 'phone': '3 26 84 02 84', 'phoneExt': '0033'}], 'facility': 'Polyclinique Courlancy', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '50420', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Renaud DE CREVOISIER, MD', 'role': 'CONTACT', 'email': 'Renaud.de.crevoisier@igr.fr', 'phone': '2 99 25 30 31', 'phoneExt': '0033'}], 'facility': 'Centre Eugène Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76038', 'city': 'Rouen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ahmed BENYOUCEF, MD', 'role': 'CONTACT', 'email': 'ahmed.Benyoucef@rouen.fnclcc.fr', 'phone': '2 32 08 22 62', 'phoneExt': '0033'}], 'facility': 'Centre Henry Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guy DE LAROCHE, MD', 'role': 'CONTACT', 'email': 'guy.delaroche@icloire.fr', 'phone': '4 77 91 71 02', 'phoneExt': '0033'}], 'facility': 'Institut Cancérologique de la Loire', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '67065', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marius POP, MD', 'role': 'CONTACT', 'email': 'mpop@strasbourg.fnclcc.fr', 'phone': '3 88 25 85 16', 'phoneExt': '0033'}], 'facility': 'Centre Paul Strauss', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31052', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'BACHAUD Jean-Marc, MD', 'role': 'CONTACT', 'email': 'bachaud.jean-marc@claudiusregaud.fr'}], 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94805', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alberto BOSSI, MD', 'role': 'CONTACT', 'email': 'Alberto.BOSSI@igr.fr'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '69626', 'city': 'Villeurbanne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'ARDIET Jean-Michel, MD', 'role': 'CONTACT', 'email': 'jean-michel.ardiet@wanadoo.fr', 'phone': '4 26 68 67 67', 'phoneExt': '0033'}], 'facility': 'Clinique du TONKIN', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}], 'centralContacts': [{'name': 'Olivier CHAPET, MD', 'role': 'CONTACT', 'email': 'olivier.chapet@chu-lyon.fr', 'phone': '0033 4 78 86 42 59'}, {'name': 'Julien BERTHILLER', 'role': 'CONTACT', 'email': 'julien.berthiller@chu-lyon.fr', 'phone': '0033 4 27 85 63 01'}], 'overallOfficials': [{'name': 'Olivier CHAPET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HCL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}