Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy (TEMPOS)
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| ClinicalTrials.gov Identifier: NCT03830788 |
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Recruitment Status :
Recruiting
First Posted : February 5, 2019
Last Update Posted : February 7, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Radiation: Radiation by brachytherapy Radiation: Radiation by SBRT | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 240 participants |
| Allocation: | Non-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 |
| Actual Study Start Date : | October 4, 2019 |
| Estimated Primary Completion Date : | October 4, 2029 |
| Estimated Study Completion Date : | October 4, 2030 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Brachytherapy
radiation by brachytherapy: brachytherapy by Iodine 125 delivering 144 Gy to the prostate
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Radiation: Radiation by brachytherapy
Brachytherapy by Iodine 125 delivering 144 Gy to the prostate |
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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.
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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. |
- 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.
- 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.
- Cost-utility analysis of avoided erectile dysfunction cost [ Time Frame: 3 and 5 years after treatment ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
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
| Contact: Martine Gestin, PhD | +33(0)299253036 | m.gestin@rennes.unicancer.fr |
| 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 | Recruiting |
| Bordeaux, France | |
| Principal Investigator: François Guichard, MD | |
| CLCC Georges-François Leclerc | Recruiting |
| Dijon, France | |
| Principal Investigator: Magali Quivrin, MD | |
| Centre de Cobalthérapie Hartman | Not yet recruiting |
| Levallois-Perret, France | |
| Principal Investigator: Laurent Chauveinc, MD | |
| CH Lyon Sud | Not yet recruiting |
| Lyon, France | |
| Contact: Sonia Gaudioz sonia.gaudioz@chu-lyon.fr | |
| Principal Investigator: Olivier CHAPET | |
| Institut régional du Cancer de Montpellier | Not yet recruiting |
| Montpellier, France | |
| Principal Investigator: Carmen Llacer-Moscardo, MD | |
| Hôpital Lyon Sud | 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 | Recruiting |
| Rennes, France, 35042 | |
| Contact: Renaud De Crevoisier, MD +33 (0)2 99 25 30 31 r.de-crevoisier@rennes.unicancer.fr | |
| Principal Investigator: Renaud De Crevoisier, MD | |
| 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 | Recruiting |
| Vandœuvre-lès-Nancy, France | |
| Principal Investigator: Didier Peiffert, MD | |
| Gustave Roussy | Recruiting |
| Villejuif, France | |
| Principal Investigator: Pierre Blanchard, MD | |
| Principal Investigator: | Renaud De Crevoisier, PR | Centre Eugène Marquis |
| Responsible Party: | Center Eugene Marquis |
| ClinicalTrials.gov Identifier: | NCT03830788 |
| Other Study ID Numbers: |
2016-2-10-003 |
| First Posted: | February 5, 2019 Key Record Dates |
| Last Update Posted: | February 7, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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SBRT brachytherapy localized low-risk and intermediate risk prostate cancer |
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Prostatic Neoplasms Erectile Dysfunction Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders |