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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03830788




Registration number
NCT03830788
Ethics application status
Date submitted
31/01/2019
Date registered
5/02/2019
Date last updated
1/10/2024

Titles & IDs
Public title
Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy
Scientific title
Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy
Secondary ID [1] 0 0
2016-2-10-003
Universal Trial Number (UTN)
Trial acronym
TEMPOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Mental Health 0 0 0 0
Other mental health disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Radiation by brachytherapy
Treatment: Other - Radiation by SBRT

Active comparator: Brachytherapy - 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.


Treatment: Other: Radiation by brachytherapy
Brachytherapy by Iodine 125 delivering 144 Gy to the prostate

Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy
Timepoint [1] 0 0
3 years after treatment.
Secondary outcome [1] 0 0
Cost-utility analysis of SBRT compared to "standard" iodine-125 brachytherapy
Timepoint [1] 0 0
5 years after treatment
Secondary outcome [2] 0 0
Cost-utility analysis of avoided erectile dysfunction cost
Timepoint [2] 0 0
3 and 5 years after treatment

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/04/2031
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Albi
Country [2] 0 0
France
State/province [2] 0 0
Angers
Country [3] 0 0
France
State/province [3] 0 0
Bordeaux
Country [4] 0 0
France
State/province [4] 0 0
Dijon
Country [5] 0 0
France
State/province [5] 0 0
La Garenne-Colombes
Country [6] 0 0
France
State/province [6] 0 0
Levallois-Perret
Country [7] 0 0
France
State/province [7] 0 0
Lyon
Country [8] 0 0
France
State/province [8] 0 0
Montpellier
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Pierre-Bénite
Country [11] 0 0
France
State/province [11] 0 0
Reims
Country [12] 0 0
France
State/province [12] 0 0
Rennes
Country [13] 0 0
France
State/province [13] 0 0
Saint-Doulchard
Country [14] 0 0
France
State/province [14] 0 0
Saint-Herblain
Country [15] 0 0
France
State/province [15] 0 0
Saint-Priest-en-Jarez
Country [16] 0 0
France
State/province [16] 0 0
Toulouse
Country [17] 0 0
France
State/province [17] 0 0
Tours
Country [18] 0 0
France
State/province [18] 0 0
Vandœuvre-lès-Nancy
Country [19] 0 0
France
State/province [19] 0 0
Villejuif

Funding & Sponsors
Primary sponsor type
Other
Name
Center Eugene Marquis
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03830788
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Renaud De Crevoisier, PR
Address 0 0
Centre Eugène Marquis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Martine Gestin, PhD
Address 0 0
Country 0 0
Phone 0 0
+33(0)299253036
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03830788