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

July 31, 2025 updated by: Center Eugene Marquis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Albi, France
        • Not yet recruiting
        • Clinique Claude Bernard
        • Principal Investigator:
          • Laurent VOTRON, MD
      • Angers, France, 49055
        • Recruiting
        • ICO Paul Papin
        • Principal Investigator:
          • COLLIAUX Jérémy, Dr
      • Bordeaux, France
        • Not yet recruiting
        • Institut Bergonie
        • Principal Investigator:
          • Paul Sargos
        • Contact:
          • Paul SARGOS, MD
      • Bordeaux, France
        • Recruiting
        • Polyclinique Bordeaux-Aquitaine
        • Principal Investigator:
          • François Guichard, MD
      • Dijon, France
        • Recruiting
        • CLCC Georges-François Leclerc
        • Principal Investigator:
          • Magali QUIVRIN, MD
      • La Garenne-Colombes, France, 92250
        • Recruiting
        • Centre Amethys - Charlebourg - La Défense
        • Principal Investigator:
          • BOSSI Alberto, Dr
      • Levallois-Perret, France
        • Not yet recruiting
        • Centre de Cobalthérapie Hartman
        • Principal Investigator:
          • Laurent Chauveinc, MD
      • Lyon, France
        • Terminated
        • CH Lyon Sud
      • Montpellier, France
        • Not yet recruiting
        • Institut Régional du Cancer de Montpellier
        • Principal Investigator:
          • Carmen Llacer-Moscardo, MD
      • Paris, France, 75005
        • Recruiting
        • Institut Curie
        • Principal Investigator:
          • CREHANGE Gilles, Pr
      • Pierre-Bénite, France
        • Terminated
        • Hôpital Lyon Sud
      • Reims, France
        • Not yet recruiting
        • Institut Jean Godinot
        • Principal Investigator:
          • Grégoire Bouché, MD
      • Rennes, France, 35042
        • Recruiting
        • Centre Eugène Marquis
        • Principal Investigator:
          • Renaud DE CREVOISIER, MD
        • Contact:
      • Saint-Doulchard, France
        • Recruiting
        • Centre d'oncologie et de radiothérapie Saint Jean
        • Principal Investigator:
          • FREDERIC-MOREAU Thomas, DR
      • Saint-Herblain, France
        • Recruiting
        • Institut de Cancérologie de l'Ouest - Site Gauducheau
        • Principal Investigator:
          • Stephane SUPIOT, MD
      • Saint-Priest-en-Jarez, France
        • Not yet recruiting
        • Institut de Cancérologie Lucien Neuwirth
        • Principal Investigator:
          • Julien Langrand-Escure, MD
      • Toulouse, France
        • Not yet recruiting
        • Institut Claudius Regaud
        • Principal Investigator:
          • Pierre Graff-Cailleaud, MD
      • Tours, France
        • Recruiting
        • CHU Tours - Hôpital Bretonneau
        • Principal Investigator:
          • Gilles Calais, Pr
      • Vandœuvre-lès-Nancy, France
        • Recruiting
        • Institut de Cancérologie de Lorraine
        • Principal Investigator:
          • Nicolas DEMOGEOT, Dr
      • Villejuif, France
        • Recruiting
        • Gustave Roussy
        • Principal Investigator:
          • Pierre Blanchard, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Brachytherapy
radiation by brachytherapy: brachytherapy by Iodine 125 delivering 144 Gy to the prostate
Radiation: Radiation by brachytherapy
Brachytherapy by Iodine 125 delivering 144 Gy to the prostate
Experimental: stereotactic body radiotherapy (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.
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center Eugene Marquis

Investigators

  • Principal Investigator: Renaud De Crevoisier, PR, Centre Eugène Marquis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2019

Primary Completion (Estimated)

April 4, 2030

Study Completion (Estimated)

April 4, 2031

Study Registration Dates

First Submitted

January 31, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (Actual)

February 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 31, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-2-10-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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