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

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ClinicalTrials.gov Identifier: NCT03830788
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Center Eugene Marquis

Brief Summary:

The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, randomized-controlled 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiation by brachytherapy Radiation: Radiation by SBRT Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Cost-utility analysis of avoided erectile dysfunction cost [ Time Frame: 3 and 5 years after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Main inclusion criteria

  • Biopsy proven prostate adenocarcinoma,
  • Low risk prostate cancer according to d'Amico criteria or favorable intermediate risk prostate cancer according Zumsteg,
  • Indication of a curative treatment by brachytherapy validated in multidisciplinary consultation meeting,
  • Patient with IIEF-6 score > 16.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830788


Contacts
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Contact: Martine Gestin, PhD +33(0)299253036 m.gestin@rennes.unicancer.fr

Locations
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France
Clinique Claude Bernard Not yet recruiting
Albi, France
Principal Investigator: Laurent Votron, MD         
Institut Bergonié Not yet recruiting
Bordeaux, France
Contact: Paul Sargos, MD         
Principal Investigator: Paul Sargos         
Polyclinique Bordeaux-Aquitaine Not yet recruiting
Bordeaux, France
Principal Investigator: François Guichard, MD         
CLCC Georges-François Leclerc
Dijon, France
Centre de Cobalthérapie Hartman Not yet recruiting
Levallois-Perret, France
Principal Investigator: Laurent Chauveinc, MD         
CH Lyon Sud
Lyon, France
Institut régional du Cancer de Montpellier Not yet recruiting
Montpellier, France
Principal Investigator: Carmen Llacer-Moscardo, MD         
Hôpital Lyon Sud Not yet recruiting
Pierre-Bénite, France
Principal Investigator: Olivier Chapet, Pr         
Institut Jean Godinot Not yet recruiting
Reims, France
Principal Investigator: Grégoire Bouché, MD         
Centre Eugene Marquis
Rennes, France, 35042
Institut de Cancérologie de l'Ouest - Site Gauducheau Not yet recruiting
Saint-Herblain, France
Principal Investigator: Stéphane Supiot, MD         
Institut de Cancérologie Lucien Neuwirth Not yet recruiting
Saint-Priest-en-Jarez, France
Principal Investigator: Julien Langrand-Escure, MD         
Institut Claudius Régaud Not yet recruiting
Toulouse, France
Principal Investigator: Pierre Graff-Cailleaud, MD         
CHU Tours - Hôpital Bretonneau Not yet recruiting
Tours, France
Principal Investigator: Gilles Calais, Pr         
Institut de Cancérologie de Lorraine Not yet recruiting
Vandœuvre-lès-Nancy, France
Principal Investigator: Didier Peiffert, MD         
Gustave Roussy Not yet recruiting
Villejuif, France
Principal Investigator: Pierre Blanchard, MD         
Sponsors and Collaborators
Center Eugene Marquis
Investigators
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Principal Investigator: Renaud De Crevoisier, PR Centre Eugène Marquis

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Responsible Party: Center Eugene Marquis
ClinicalTrials.gov Identifier: NCT03830788     History of Changes
Other Study ID Numbers: 2016-2-10-003
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Center Eugene Marquis:
SBRT
brachytherapy
localized low-risk and favorable intermediate risk prostate cancer

Additional relevant MeSH terms:
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Erectile Dysfunction
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders