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

Prostate Cancer Clinical Trial

— TEMPOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03830788
• Other study ID #: 2016-2-10-003
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2019
• Est. completion date: October 4, 2030

Study information

• Verified date: February 2024
• Source: Center Eugene Marquis
• Contact: Martine Gestin, PhD
• Phone: +33(0)299253036
• Email: m.gestin[@]rennes.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 4, 2030
• Est. primary completion date: October 4, 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
France	Clinique Claude Bernard	Albi
France	Institut Bergonié	Bordeaux
France	Polyclinique Bordeaux-Aquitaine	Bordeaux
France	CLCC Georges-François Leclerc	Dijon
France	Centre de Cobalthérapie Hartman	Levallois-Perret
France	CH Lyon Sud	Lyon
France	Institut régional du Cancer de Montpellier	Montpellier
France	Hôpital Lyon Sud	Pierre-Bénite
France	Institut Jean Godinot	Reims
France	Centre Eugene Marquis	Rennes
France	Institut de Cancérologie de l'Ouest - Site Gauducheau	Saint-Herblain
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez
France	Institut Claudius Régaud	Toulouse
France	CHU Tours - Hôpital Bretonneau	Tours
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy
France	Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years after treatment.
Secondary	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.	5 years after treatment
Secondary	Cost-utility analysis of avoided erectile dysfunction cost		3 and 5 years after treatment