Informations générales (source: ClinicalTrials.gov)

NCT03830788 En recrutement IDF
Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy (TEMPOS)
Interventional
  • Dysfonctionnement érectile
  • Tumeurs de la prostate
N/A
Center Eugene Marquis (Voir sur ClinicalTrials)
octobre 2019
avril 2031
02 octobre 2024
The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, medico-economic study comparing brachytherapy to SBRT in low and intermediate risk prostate cancer, particularly focused on the issue of erectile dysfunction. A total of 240 potent patients are randomized in two arms. The experimental arm consists of SBRT delivering 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. The control arm consists of brachytherapy by Iodine 125 delivering 144 Gy to the prostate. The main objective of this health economics study is to perform a cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy in low-risk prostate cancer, 3 years after treatment. The endpoint is the Incremental Cost-Utility Ratio (ICUR) between SBRT and brachytherapy as primary criterion, expressed in cost per quality adjusted life year (QALY) gained. Cost-effectiveness analyses are performed as secondary objective with Incremental Cost-Effectiveness Ratios (ICERs) expressed as cost per erectile dysfunction avoided and cost per Life Year Gained. A long term evaluation is also performed, including a cost-utility, cost-effectiveness and budget impact analysis at 5 years, a comprehensive assessment of the erectile dysfunction up to 5 years after treatment, an evaluation of acute and late genito-urinary (GU) and Gastro-Intestinal (GI) toxicities, and of quality of life up to 5 years after treatment. Eight patients/year/center are expected to be recruited in 2 years in about twenty participating centers. In total, to our knowledge, this study will be the first health economic evaluation which compares SBRT versus Iodine 125 brachytherapy in low risk and intermediate risk prostate cancer. Both cost-utility and cost-effectiveness analyses will also provide useful and complementary information to decision makers in order (i) to recommend the best strategy to adopt; (ii) to estimate the budget impact on the French National Health Insurance of the generalization of the cost-effective strategy. Finally, this study will allow to assess and compare accurately the erectile dysfunction after both treatment modalities.
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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 En recrutement IDF 04/09/2024 13:49:46 Contact (sur clinicalTrials)
CLCC INSTITUT GUSTAVE ROUSSY Pierre BLANCHARD En recrutement IDF 11/04/2024 11:09:34  Contacter
CLCC RENE HUGUENIN INSTITUT CURIE En recrutement IDF 04/09/2024 13:49:31 Contact (sur clinicalTrials)
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CPEF LEVALLOIS PERRET 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 Eugene Marquis - 35042 - Rennes - France Renaud De Crevoisier, MD En recrutement Contact (sur clinicalTrials)
CH Lyon Sud - Lyon - France Terminé Contact (sur clinicalTrials)
CHU Tours - Hôpital Bretonneau - Tours - France En recrutement Contact (sur clinicalTrials)
Clinique Claude Bernard - Albi - France Recrutement non commencé Contact (sur clinicalTrials)
Hôpital Lyon Sud - Pierre-Bénite - France Terminé Contact (sur clinicalTrials)
Institut Claudius Régaud - Toulouse - France Recrutement non commencé Contact (sur clinicalTrials)
Institut de Cancérologie Lucien Neuwirth - Saint-Priest-en-Jarez - France Recrutement non commencé Contact (sur clinicalTrials)
Institut Jean Godinot - Reims - France Recrutement non commencé 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 Amethys - Charlebourg - La Défense - 92250 - La Garenne-Colombes - France Recrutement non commencé Contact (sur clinicalTrials)
Centre d'oncologie et de radiothérapie Saint Jean - Saint-Doulchard - France Recrutement non commencé Contact (sur clinicalTrials)
Gustave Roussy - Villejuif - France En recrutement Contact (sur clinicalTrials)
ICO Paul Papin - 49055 - Angers - France En recrutement Contact (sur clinicalTrials)
Institut de Cancérologie de Lorraine - Vandœuvre-lès-Nancy - France En recrutement Contact (sur clinicalTrials)
Institut régional du Cancer de Montpellier - Montpellier - France Recrutement non commencé Contact (sur clinicalTrials)
Polyclinique Bordeaux-Aquitaine - Bordeaux - France En recrutement Contact (sur clinicalTrials)

Critères

Homme
Main inclusion criteria

- Biopsy proven prostate adenocarcinoma,

- Low risk prostate cancer according to d'Amico (T1-T2a and PSA <10 ng/ml, and Gleason
score 6) or intermediate risk prostate cancer according d'Amico but excluding tumor
with Gleason score 7 (4 + 3),

- Indication of a curative treatment by brachytherapy validated in multidisciplinary
consultation meeting,

Main exclusion criteria

- Androgen deprivation therapy,

- Contraindication for prostate Iodine 125 brachytherapy (Prostate volume > 50 cc,
impossibility if general anesthesia).

- Contraindication for Resonance Magnetic Imagery (RMI) (claustrophobia, pacemaker)

- Participation to another research which could have an impact on the study treatment
and the outcomes