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Prostate CancerTEMPOSNCT03830788

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

A study testing Radiation by brachytherapy and Radiation by SBRT in people with Prostate Cancer, run by Center Eugene Marquis at 20 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Radiation by brachytherapy and Radiation by SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
20 sitesFrance
Study dates
4 Oct 2019to 4 Apr 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Martine Gestin, PhD contact

+33(0)299253036

m.gestin@rennes.unicancer.fr

20 sites in 1 country

France20 sites, 18 recruiting

  • Clinique Claude Bernard

    Albi

    Laurent Votron, MD

    Not yet recruiting

  • ICO Paul Papin

    Angers, 49055

    COLLIAUX Jérémy, Dr

    Recruiting

  • Institut Bergonié

    Bordeaux

    Paul Sargos, MD

    Paul Sargos

    Not yet recruiting

  • Polyclinique Bordeaux-Aquitaine

    Bordeaux

    François Guichard, MD

    Recruiting

  • CLCC Georges-François Leclerc

    Dijon

    Magali Quivrin, MD

    Recruiting

  • Centre Amethys - Charlebourg - La Défense

    La Garenne-Colombes, 92250

    BOSSI Alberto, Dr

    Recruiting

  • Centre de Cobalthérapie Hartman

    Levallois-Perret

    Laurent Chauveinc, MD

    Not yet recruiting

  • CH Lyon Sud

    Lyon

    Terminated

  • Institut régional du Cancer de Montpellier

    Montpellier

    Carmen Llacer-Moscardo, MD

    Not yet recruiting

  • Institut Curie

    Paris, 75005

    CRÉHANGE Gilles, Pr

    Recruiting

  • Hôpital Lyon Sud

    Pierre-Bénite

    Terminated

  • Institut Jean Godinot

    Reims

    Grégoire Bouché, MD

    Not yet recruiting

  • Centre Eugene Marquis

    Rennes, 35042

    Renaud De Crevoisier, MD, +33 (0)2 99 25 30 31, r.de-crevoisier@rennes.unicancer.fr

    Renaud De Crevoisier, MD

    Recruiting

  • Centre d'oncologie et de radiothérapie Saint Jean

    Saint-Doulchard

    FREDERIC-MOREAU Thomas, DR

    Recruiting

  • Institut de Cancérologie de l'Ouest - Site Gauducheau

    Saint-Herblain

    Stéphane Supiot, MD

    Recruiting

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez

    Julien Langrand-Escure, MD

    Not yet recruiting

  • Institut Claudius Régaud

    Toulouse

    Pierre Graff-Cailleaud, MD

    Not yet recruiting

  • CHU Tours - Hôpital Bretonneau

    Tours

    Gilles Calais, Pr

    Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy

    Nicolas DEMOGEOT, Dr

    Recruiting

  • Gustave Roussy

    Villejuif

    Pierre Blanchard, MD

    Recruiting

Other trials in France

About this study

Official title: Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy

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
Prostate Cancer
Being tested
Radiation by brachytherapy, Radiation by SBRT
Keywords
SBRT, brachytherapy, localized low-risk and intermediate risk prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation by brachytherapyRadiation

    Brachytherapy by Iodine 125 delivering 144 Gy to the prostate

  • Radiation by SBRTRadiation

    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.

Study groups in NCT03830788
Study groupRoleWhat they receive
BrachytherapyActive comparatorradiation by brachytherapy: brachytherapy by Iodine 125 delivering 144 Gy to the prostate
Receives: Radiation: Radiation by brachytherapy
stereotactic body radiotherapy (SBRT)Experimentalradiation 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.
Receives: Radiation: Radiation by SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy

    The cost-utility analysis is expressed in cost per quality adjusted life year (QALY) gained.

    Measured: 3 years after treatment.

Secondary outcomes (2)

  1. Cost-utility analysis of SBRT compared to "standard" iodine-125 brachytherapy

    The cost-utility analysis is expressed in cost per quality adjusted life year (QALY) gained.

    Measured: 5 years after treatment

  2. Cost-utility analysis of avoided erectile dysfunction cost

    Measured: 3 and 5 years after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2019
  2. Study start4 Oct 2019
  3. Primary completion4 Apr 2030 (estimated)
  4. Study completion4 Apr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03830788
Sponsor's protocol ID
2016-2-10-003
Acronym
TEMPOS
Status last verified
Jul 2025
First submitted
31 Jan 2019
Last updated
1 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Radiation by brachytherapy and Radiation by SBRT in people with Prostate Cancer, run by Center Eugene Marquis at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martine Gestin, PhD (+33(0)299253036, m.gestin@rennes.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy (time frame: 3 years after treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03830788.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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