Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy (TEMPOS)
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiation by brachytherapy
Radiation by SBRT
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring SBRT, brachytherapy, localized low-risk and intermediate risk prostate cancer
Eligibility 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
Sites / Locations
- Clinique Claude Bernard
- Institut Bergonié
- Polyclinique Bordeaux-AquitaineRecruiting
- CLCC Georges-François LeclercRecruiting
- Centre de Cobalthérapie Hartman
- CH Lyon Sud
- Institut régional du Cancer de Montpellier
- Hôpital Lyon SudRecruiting
- Institut Jean Godinot
- Centre Eugene MarquisRecruiting
- Institut de Cancérologie de l'Ouest - Site Gauducheau
- Institut de Cancérologie Lucien Neuwirth
- Institut Claudius Régaud
- CHU Tours - Hôpital Bretonneau
- Institut de Cancérologie de LorraineRecruiting
- Gustave RoussyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Brachytherapy
stereotactic body radiotherapy (SBRT)
Arm Description
radiation by brachytherapy: brachytherapy by Iodine 125 delivering 144 Gy to the prostate
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Cost-utility analysis of avoided erectile dysfunction cost
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03830788
Brief Title
Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy
Acronym
TEMPOS
Official Title
Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
October 4, 2029 (Anticipated)
Study Completion Date
October 4, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
SBRT, brachytherapy, localized low-risk and intermediate risk prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brachytherapy
Arm Type
Active Comparator
Arm Description
radiation by brachytherapy: brachytherapy by Iodine 125 delivering 144 Gy to the prostate
Arm Title
stereotactic body radiotherapy (SBRT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation by brachytherapy
Intervention Description
Brachytherapy by Iodine 125 delivering 144 Gy to the prostate
Intervention Type
Radiation
Intervention Name(s)
Radiation by SBRT
Intervention Description
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 Measure Information:
Title
Cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy
Description
The cost-utility analysis is expressed in cost per quality adjusted life year (QALY) gained.
Time Frame
3 years after treatment.
Secondary Outcome Measure Information:
Title
Cost-utility analysis of SBRT compared to "standard" iodine-125 brachytherapy
Description
The cost-utility analysis is expressed in cost per quality adjusted life year (QALY) gained.
Time Frame
5 years after treatment
Title
Cost-utility analysis of avoided erectile dysfunction cost
Time Frame
3 and 5 years after treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martine Gestin, PhD
Phone
+33(0)299253036
Email
m.gestin@rennes.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud De Crevoisier, PR
Organizational Affiliation
Centre Eugène Marquis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Claude Bernard
City
Albi
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Votron, MD
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Sargos, MD
First Name & Middle Initial & Last Name & Degree
Paul Sargos
Facility Name
Polyclinique Bordeaux-Aquitaine
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Guichard, MD
Facility Name
CLCC Georges-François Leclerc
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magali Quivrin, MD
Facility Name
Centre de Cobalthérapie Hartman
City
Levallois-Perret
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Chauveinc, MD
Facility Name
CH Lyon Sud
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Gaudioz
Email
sonia.gaudioz@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Olivier CHAPET
Facility Name
Institut régional du Cancer de Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Llacer-Moscardo, MD
Facility Name
Hôpital Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Chapet, Pr
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire Bouché, MD
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renaud De Crevoisier, MD
Phone
+33 (0)2 99 25 30 31
Email
r.de-crevoisier@rennes.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Renaud De Crevoisier, MD
Facility Name
Institut de Cancérologie de l'Ouest - Site Gauducheau
City
Saint-Herblain
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Supiot, MD
Facility Name
Institut de Cancérologie Lucien Neuwirth
City
Saint-Priest-en-Jarez
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Langrand-Escure, MD
Facility Name
Institut Claudius Régaud
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Graff-Cailleaud, MD
Facility Name
CHU Tours - Hôpital Bretonneau
City
Tours
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles Calais, Pr
Facility Name
Institut de Cancérologie de Lorraine
City
Vandœuvre-lès-Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier Peiffert, MD
Facility Name
Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Blanchard, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy
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