Informations générales (source: ClinicalTrials.gov)

NCT02271659 Statut inconnu
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 (GETUGP05)
Interventional
  • Tumeurs de la prostate
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
juin 2013
juin 2021
29 juin 2024
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. The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC INSTITUT CURIE Active, sans recrutement 10/04/2025 13:12:21  Contacter
CLCC INSTITUT GUSTAVE ROUSSY Alberto BOSSI Complet 08/01/2024 09:12:51  Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Europeen Georges Pompidou Martin HOUSSET, MD Recrutement non commencé Contact (sur clinicalTrials)
CH RIVES DE SEINE SITE NEUILLY S/SEINE Laurent CHAUVEINC, MD Recrutement non commencé Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Antoine Lacassagne - 06189 - Nice - France Jean-Michel HANNOUN LEVI, MD Recrutement non commencé Contact (sur clinicalTrials)
Centre Eugène Marquis - 50420 - Rennes - France Renaud DE CREVOISIER, MD En recrutement Contact (sur clinicalTrials)
Centre Francois Baclesse - 14076 - Caen - France Marlon SILVA, MD Recrutement non commencé Contact (sur clinicalTrials)
Centre Georges François Leclerc - 21079 - Dijon - France Gilles CREHANGE, MD En recrutement Contact (sur clinicalTrials)
Centre Henry Becquerel - 76038 - Rouen - France Ahmed BENYOUCEF, MD Recrutement non commencé Contact (sur clinicalTrials)
Centre Paul Strauss - 67065 - Strasbourg - France Marius POP, MD En recrutement Contact (sur clinicalTrials)
Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard - 69373 - Lyon - France Pascal POMMIER, MD En recrutement Contact (sur clinicalTrials)
CHRU Morvan - 29609 - Brest - France Jean-Pierre MALHAIRE, MD En recrutement Contact (sur clinicalTrials)
CHU Jean MINJOZ - 25030 - Besançon - France Yasser HAMMOUD, MD Recrutement non commencé Contact (sur clinicalTrials)
CHU Poitiers - 86021 - Poitiers - France Stéphane GUERIF, MD En recrutement Contact (sur clinicalTrials)
Clinique Claude Bernard - 81000 - Albi - France Laurent VOTRON, MD En recrutement Contact (sur clinicalTrials)
Clinique du TONKIN - 69626 - Villeurbanne - France ARDIET Jean-Michel, MD Recrutement non commencé Contact (sur clinicalTrials)
Hopital de la Tronche - 38043 - Grenoble - France Michel BOLLA, MD En recrutement Contact (sur clinicalTrials)
Hopital Saint-Louis - 75475 - Paris - France Christophe HENNEQUIN, MD En recrutement Contact (sur clinicalTrials)
Hospices Civils de Lyon - 69495 - Pierre-Bénite - France Olivier CHAPET, MD En recrutement Contact (sur clinicalTrials)
Institut Claudius Regaud - 31052 - Toulouse - France BACHAUD Jean-Marc, MD En recrutement Contact (sur clinicalTrials)
Institut de Cancerologie de Lorraine Alexis Vautrin - 54519 - Nancy - France Didier PEIFFERT, MD En recrutement Contact (sur clinicalTrials)
Institut Jean Godinot, - 51056 - Reims - France Tan Dat NGUYEN, MD Recrutement non commencé Contact (sur clinicalTrials)
Polyclinique Courlancy - 51057 - Reims - France Frédéric MALLET, MD En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre d'oncologie et de radiothérapie Mâcon - 71031 - Macon - France Fabrice LORCHEL, MD Recrutement non commencé Contact (sur clinicalTrials)
Centre Val D'Aurelle - 34298 - Montpellier - France Carmen LLACER MOSCARDO, MD En recrutement Contact (sur clinicalTrials)
Clinique Tivoli - 33000 - Bordeaux - France Nathalie BONICHON-LAMICHHANE, MD En recrutement Contact (sur clinicalTrials)
Institut Cancérologique de la Loire - 42270 - Saint-priest En Jarez - France Guy DE LAROCHE, MD En recrutement Contact (sur clinicalTrials)
Institut Paoli Calmette - 13273 - Marseille - France Naji SALEM, MD En recrutement Contact (sur clinicalTrials)

Critères

Homme
Inclusion Criteria:

- age between 18 and 80 years;

- life expectancy of greater than 10 years;

- prostate adenocarcinoma histologically proven;

- 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.

- the patient has to be the beneficiary of the social security system (order n°
2006-477 from April 26th 2006);

- the signed consent form.


- PSA level > 20;

- Gleason > 7;

- clinical T3A or T3B or MRI (a simple suspicion/ doubt on the MRI regarding the T3A
won't be an exclusion criterion);

- prostate volume > 60 cc;

- pelvic lymph nodes involvement at dissection or imaging (ADP > 1.5 cm);

- concurrent hormone therapy;

- the presence of distant metastasis (M1);

- history of abdominal or pelvic irradiation;

- history of prostate resection in the previous 6 months and/or not allowing the
implantation of markers;

- history of uncontrolled cancer and/or treated since less than 5 years (excepting the
basal-cell carcinoma);

- urinary discomfort with an IPSS (International Prostate Symptom Score) > 15 (without
alpha-blocking);

- inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;

- other undergoing study that may interfere with the present study;

- patient under legal protection measure.