Clinical trial NCT03830788: Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy
Official title: Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: SBRT
brachytherapy
localized low-risk and intermediate risk prostate cancer
Lead sponsor: Center Eugene Marquis
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 240
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy
timeFrame: 3 years after treatment.
Secondary outcomes:
measure: Cost-utility analysis of SBRT compared to "standard" iodine-125 brachytherapy
timeFrame: 5 years after treatment
measure: Cost-utility analysis of avoided erectile dysfunction cost
timeFrame: 3 and 5 years after treatment
Other outcomes:
Locations:
city: Albi
country: France
facility: Clinique Claude Bernard
city: Angers
country: France
facility: ICO Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bordeaux
country: France
facility: Polyclinique Bordeaux-Aquitaine
city: Dijon
country: France
facility: CLCC Georges-François Leclerc
city: La Garenne-Colombes
country: France
facility: Centre Amethys - Charlebourg - La Défense
city: Levallois-Perret
country: France
facility: Centre de Cobalthérapie Hartman
city: Lyon
country: France
facility: CH Lyon Sud
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier
city: Paris
country: France
facility: Institut Curie
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Saint-Doulchard
country: France
facility: Centre d'oncologie et de radiothérapie Saint Jean
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest - Site Gauducheau
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Toulouse
country: France
facility: Institut Claudius Régaud
city: Tours
country: France
facility: CHU Tours - Hôpital Bretonneau
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Centre Eugène Marquis
name: Renaud De Crevoisier, PR
role: PRINCIPAL_INVESTIGATOR
References: