Actively Recruiting
Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy
Led by Center Eugene Marquis · Updated on 2025-08-01
240
Participants Needed
20
Research Sites
600 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 to d'Amico excluding tumor with Gleason score 7 (4 + 3)
- Indication of a curative treatment by brachytherapy validated in multidisciplinary consultation meeting
You will not qualify if you...
- Use of androgen deprivation therapy
- Contraindication for prostate Iodine 125 brachytherapy (prostate volume > 50 cc, or inability to undergo general anesthesia)
- Contraindication for Resonance Magnetic Imagery (claustrophobia, pacemaker)
- Participation in another research study that could affect the treatment or outcomes
AI-Screening
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Trial Site Locations
Total: 20 locations
1
Clinique Claude Bernard
Albi, France
Not Yet Recruiting
2
ICO Paul Papin
Angers, France, 49055
Actively Recruiting
3
Institut Bergonié
Bordeaux, France
Not Yet Recruiting
4
Polyclinique Bordeaux-Aquitaine
Bordeaux, France
Actively Recruiting
5
CLCC Georges-François Leclerc
Dijon, France
Actively Recruiting
6
Centre Amethys - Charlebourg - La Défense
La Garenne-Colombes, France, 92250
Actively Recruiting
7
Centre de Cobalthérapie Hartman
Levallois-Perret, France
Not Yet Recruiting
8
CH Lyon Sud
Lyon, France
Terminated
9
Institut régional du Cancer de Montpellier
Montpellier, France
Not Yet Recruiting
10
Institut Curie
Paris, France, 75005
Actively Recruiting
11
Hôpital Lyon Sud
Pierre-Bénite, France
Terminated
12
Institut Jean Godinot
Reims, France
Not Yet Recruiting
13
Centre Eugene Marquis
Rennes, France, 35042
Actively Recruiting
14
Centre d'oncologie et de radiothérapie Saint Jean
Saint-Doulchard, France
Actively Recruiting
15
Institut de Cancérologie de l'Ouest - Site Gauducheau
Saint-Herblain, France
Actively Recruiting
16
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France
Not Yet Recruiting
17
Institut Claudius Régaud
Toulouse, France
Not Yet Recruiting
18
CHU Tours - Hôpital Bretonneau
Tours, France
Actively Recruiting
19
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Actively Recruiting
20
Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
M
Martine Gestin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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