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

RecruitingNAAges 18 Years - anyMaleCenter Eugene Marquis
NCT03830788 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-e

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📋 Eligibility rules (as published)
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
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What it tests

  • Radiation by brachytherapy
  • Radiation by SBRT
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Where

20 sites
Clinique Claude Bernard
Albi, France
ICO Paul Papin
Angers, France
Institut Bergonié
Bordeaux, France
Polyclinique Bordeaux-Aquitaine
Bordeaux, France
CLCC Georges-François Leclerc
Dijon, France
Centre Amethys - Charlebourg - La Défense
La Garenne-Colombes, France
Centre de Cobalthérapie Hartman
Levallois-Perret, France
CH Lyon Sud
Lyon, France

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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