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Taking people in FranceNo phase

Compares two radiation treatments for early prostate cancer and erectile dysfunction

Compares stereotactic radiotherapy with iodine 125 seed brachytherapy in men with prostate cancer.

Key facts

Who runs it
Center Eugene Marquis
Where
Albi, Angers, Bordeaux, Dijon, La Garenne-Colombes, Levallois-Perret, Lyon, Montpellier, Paris, Pierre-Bénite, Reims, Rennes, Saint-Doulchard, Saint-Herblain, Saint-Priest-en-Jarez, Toulouse, Tours, Vandœuvre-lès-Nancy, and Villejuif, FranceSee the 20 sites
Trial code
Registry title
Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy
Status
Recruiting
People taking part
240 people, planned
Started
4 Oct 2019
Expected to end
4 Apr 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Radiation by brachytherapy
  • Radiation by SBRT
Record updated
1 August 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with low or intermediate risk prostate cancer who can still have erections. It compares brachytherapy with stereotactic body radiotherapy (SBRT).

Age
18 years or older
Sex
Men only
Disease stage
Low risk prostate cancer (T1-T2a, PSA under 10 ng/ml, Gleason score 6) or intermediate risk prostate cancer, but not Gleason score 7 (4 + 3). The cancer must be confirmed by biopsy.
Earlier treatment
Treatment with androgen deprivation therapy is not allowed.

Main reasons for not taking part

  • Androgen deprivation therapy
  • Prostate volume over 50 cc or cannot have general anesthesia, which rules out Iodine 125 brachytherapy
  • Cannot have an MRI scan (for example claustrophobia or a pacemaker)
  • Taking part in another research study that could affect the study treatment or results

The registry criteria, word for word

Show all 8 criteriaShow less

Other 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

Where in France

  • Clinique Claude BernardAlbi, FranceContact: Laurent Votron, MD (principal investigator)Not yet recruiting
  • ICO Paul PapinAngers, FranceContact: COLLIAUX Jérémy, Dr (principal investigator)Taking people
  • Institut BergonieBordeaux, FranceContact: Paul Sargos, MDNot yet recruiting
  • Polyclinique Bordeaux-AquitaineBordeaux, FranceContact: François Guichard, MD (principal investigator)Taking people
  • Clcc Georges Francois LeclercDijon, FranceContact: Magali Quivrin, MD (principal investigator)Taking people
  • Centre Amethys - Charlebourg - La DéfenseLa Garenne-Colombes, FranceContact: BOSSI Alberto, Dr (principal investigator)Taking people
  • Centre de Cobalthérapie HartmanLevallois-Perret, FranceContact: Laurent Chauveinc, MD (principal investigator)Not yet recruiting
  • CH Lyon SudLyon, FranceContact: Martine Gestin, PhDNo longer taking part
  • Institut Regional Du Cancer de MontpellierMontpellier, FranceContact: Carmen Llacer-Moscardo, MD (principal investigator)Not yet recruiting
  • Institut CurieParis, FranceContact: CRÉHANGE Gilles, Pr (principal investigator)Taking people
  • Hopital Lyon SudPierre-Bénite, FranceContact: Martine Gestin, PhDNo longer taking part
  • Institut Jean GodinotReims, FranceContact: Grégoire Bouché, MD (principal investigator)Not yet recruiting
  • Centre Eugène MarquisRennes, FranceContact: Renaud De Crevoisier, MDTaking people
  • Centre d'oncologie et de radiothérapie Saint JeanSaint-Doulchard, FranceContact: FREDERIC-MOREAU Thomas, DR (principal investigator)Taking people
  • Institut de Cancérologie de l'Ouest - Site GauducheauSaint-Herblain, FranceContact: Stéphane Supiot, MD (principal investigator)Taking people
  • Institut de Cancérologie Lucien NeuwirthSaint-Priest-en-Jarez, FranceContact: Julien Langrand-Escure, MD (principal investigator)Not yet recruiting
  • Institut Claudius RegaudToulouse, FranceContact: Pierre Graff-Cailleaud, MD (principal investigator)Not yet recruiting
  • CHU Tours Hôpital BretonneauTours, FranceContact: Gilles Calais, Pr (principal investigator)Taking people
  • Institut de Cancérologie de LorraineVandœuvre-lès-Nancy, FranceContact: Nicolas DEMOGEOT, Dr (principal investigator)Taking people
  • Gustave RoussyVillejuif, FranceContact: Pierre Blanchard, MD (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • BrachytherapyExisting treatment, for comparison

    radiation by brachytherapy: brachytherapy by Iodine 125 delivering 144 Gy to the prostate

    Treatment: Radiation by brachytherapy

  • stereotactic body radiotherapy (SBRT)Treatment being tested

    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.

    Treatment: Radiation by SBRT

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy
Plain-language title
Compares two radiation treatments for early prostate cancer and erectile dysfunctionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
1 August 2025