Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Radiation by brachytherapy; Radiation: Radiation by SBRT

• Registration Number: NCT03830788
• Lead Sponsor: Center Eugene Marquis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Study Start: 2019-10-04
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2030-04-04
• Study Completion: 2031-04-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brachytherapy	Radiation by brachytherapy	radiation by brachytherapy: brachytherapy by Iodine 125 delivering 144 Gy to the prostate
stereotactic body radiotherapy (SBRT)	Radiation by 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.

Primary Outcome Measures

Name	Time	Method
Cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy	3 years after treatment.	The cost-utility analysis is expressed in cost per quality adjusted life year (QALY) gained.

Secondary Outcome Measures

Name	Time	Method
Cost-utility analysis of avoided erectile dysfunction cost	3 and 5 years after treatment
Cost-utility analysis of SBRT compared to "standard" iodine-125 brachytherapy	5 years after treatment	The cost-utility analysis is expressed in cost per quality adjusted life year (QALY) gained.

Trial Locations

Locations (20)

ICO Paul Papin; 🇫🇷 Angers, France

Centre Amethys - Charlebourg - La Défense; 🇫🇷 La Garenne-Colombes, France

Institut Curie; 🇫🇷 Paris, France

Centre d'oncologie et de radiothérapie Saint Jean; 🇫🇷 Saint-Doulchard, France

Clinique Claude Bernard; 🇫🇷 Albi, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Polyclinique Bordeaux-Aquitaine; 🇫🇷 Bordeaux, France

CLCC Georges-François Leclerc; 🇫🇷 Dijon, France

Centre de Cobalthérapie Hartman; 🇫🇷 Levallois-Perret, France

CH Lyon Sud; 🇫🇷 Lyon, France

Institut régional du Cancer de Montpellier; 🇫🇷 Montpellier, France

Hôpital Lyon Sud; 🇫🇷 Pierre-Bénite, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Institut de Cancérologie de l'Ouest - Site Gauducheau; 🇫🇷 Saint-Herblain, France

Institut de Cancérologie Lucien Neuwirth; 🇫🇷 Saint-Priest-en-Jarez, France

Institut Claudius Régaud; 🇫🇷 Toulouse, France

CHU Tours - Hôpital Bretonneau; 🇫🇷 Tours, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France

Gustave Roussy; 🇫🇷 Villejuif, France