Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy

Who is this study for? Adult patients with prostate cancer
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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,

Locations
Other Locations
France
Clinique Claude Bernard
NOT_YET_RECRUITING
Albi
ICO Paul Papin
RECRUITING
Angers
Institut Bergonié
NOT_YET_RECRUITING
Bordeaux
Polyclinique Bordeaux-Aquitaine
RECRUITING
Bordeaux
CLCC Georges-François Leclerc
RECRUITING
Dijon
Centre Amethys - Charlebourg - La Défense
RECRUITING
La Garenne-colombes
Centre de Cobalthérapie Hartman
NOT_YET_RECRUITING
Levallois-perret
CH Lyon Sud
TERMINATED
Lyon
Institut régional du Cancer de Montpellier
NOT_YET_RECRUITING
Montpellier
Institut Curie
RECRUITING
Paris
Hôpital Lyon Sud
TERMINATED
Pierre-bénite
Institut Jean Godinot
NOT_YET_RECRUITING
Reims
Centre Eugene Marquis
RECRUITING
Rennes
Centre d'oncologie et de radiothérapie Saint Jean
RECRUITING
Saint-doulchard
Institut de Cancérologie de l'Ouest - Site Gauducheau
RECRUITING
Saint-herblain
Institut de Cancérologie Lucien Neuwirth
NOT_YET_RECRUITING
Saint-priest-en-jarez
Institut Claudius Régaud
NOT_YET_RECRUITING
Toulouse
CHU Tours - Hôpital Bretonneau
RECRUITING
Tours
Institut de Cancérologie de Lorraine
RECRUITING
Vandœuvre-lès-nancy
Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Martine Gestin, PhD
m.gestin@rennes.unicancer.fr
+33(0)299253036
Time Frame
Start Date: 2019-10-04
Estimated Completion Date: 2031-04-04
Participants
Target number of participants: 240
Treatments
Active_comparator: Brachytherapy
radiation by brachytherapy: brachytherapy by Iodine 125 delivering 144 Gy to the prostate
Experimental: stereotactic body radiotherapy (SBRT)
radiation by SBRT: SBRT delivers 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. Fiducials are implanted in the prostate. The prostate can be tracked/localized/treated thanks to the Cyberknife or a conventional linac equipped with an ExacTrac or a Calypso4D system.
Sponsors
Leads: Center Eugene Marquis

This content was sourced from clinicaltrials.gov