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The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment.
The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brachytherapy boost | Experimental | Brachytherapy boost with external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds (110Gy) or high dose rate (14Gy) with iridium-192) only to the prostate. Each center will choose the appropriate brachytherapy technique |
|
| Exclusive external beam irradiation | Active Comparator | Exclusive external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brachytherapy boost with external beam radiotherapy | Radiation | Bras A: External beam radiotherapy of 46 Gy delivered with a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds from Bard (110Gy) or high dose rate (14Gy) with a iridium-192 source) only to the prostate. Each center will choose the appropriate brachytherapy technique. The number of seeds or needles will depend on the prostate's volume. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the biochemical relapse free survival of the patients in two groups at 5 years for an external beam radiotherapy with a brachytherapy boost versus an exclusive external beam radiotherapy | Biochemical relapse is defined using the Phoenix definition of nadir of Prostate Specific Antigen + 2 ng/ml. This will be studied for both arms | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| The evaluation of the overall survival at 5 years. | All cause mortality | 5 years |
| The evaluation of the specific survival at 5 years | Mortality due to prostate cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier CHAPET, MD | Contact | 0033 4 78 86 42 59 | olivier.chapet@chu-lyon.fr | |
| Julien BERTHILLER | Contact | 0033 4 27 85 63 01 | julien.berthiller@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Olivier CHAPET, MD | HCL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Claude Bernard | Recruiting | Albi | 81000 | France |
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|
| Exclusive external beam radiotherapy | Radiation | Bras B: External beam radiotherapy of 46 Gy delivered with photons and a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone. |
|
| 5 years |
| The evaluation of the survival without any metastatic evolution at 5 years | 5 years |
| The study of all toxicities | The toxicities include: acute and late toxicities, sexual toxicities, the quality of life of the patients (CTCAE version 4.0) | 5 years |
| Medical and economical evaluation. | The complete medical and economical evaluation of the strategies | 5 years |
| CHU Jean MINJOZ | Not yet recruiting | Besançon | 25030 | France |
|
| Clinique Tivoli | Recruiting | Bordeaux | 33000 | France |
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| Institut Bergonie | Recruiting | Bordeaux | 33076 | France |
|
| CHRU Morvan | Recruiting | Brest | 29609 | France |
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| Centre Francois Baclesse | Not yet recruiting | Caen | 14076 | France |
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| Centre Georges François Leclerc | Recruiting | Dijon | 21079 | France |
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| Hopital de la Tronche | Recruiting | Grenoble | 38043 | France |
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| Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard | Recruiting | Lyon | 69373 | France |
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| Institut Paoli Calmette | Recruiting | Marseille | 13273 | France |
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| Centre d'oncologie et de radiothérapie Mâcon | Not yet recruiting | Mâcon | 71031 | France |
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| Centre Val D'Aurelle | Recruiting | Montpellier | 34298 | France |
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| Institut de Cancerologie de Lorraine Alexis Vautrin | Recruiting | Nancy | 54519 | France |
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| Clinique Hartmann | Not yet recruiting | Neuilly-sur-Seine | 92200 | France |
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| Centre Antoine Lacassagne | Not yet recruiting | Nice | 06189 | France |
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| Institut Curie | Recruiting | Paris | 75248 | France |
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| Hopital Saint-Louis | Recruiting | Paris | 75475 | France |
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| Hopital George Pompidou | Not yet recruiting | Paris | 75908 | France |
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| Hospices Civils de Lyon | Recruiting | Pierre-Bénite | 69495 | France |
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| CHU Poitiers | Recruiting | Poitiers | 86021 | France |
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| Institut Jean Godinot, | Not yet recruiting | Reims | 51056 | France |
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| Polyclinique Courlancy | Recruiting | Reims | 51057 | France |
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| Centre Eugène Marquis | Recruiting | Rennes | 50420 | France |
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| Centre Henry Becquerel | Not yet recruiting | Rouen | 76038 | France |
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| Institut Cancérologique de la Loire | Recruiting | Saint-Priest-en-Jarez | 42270 | France |
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| Centre Paul Strauss | Recruiting | Strasbourg | 67065 | France |
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| Institut Claudius Regaud | Recruiting | Toulouse | 31052 | France |
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| Institut Gustave Roussy | Recruiting | Villejuif | 94805 | France |
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| Clinique du TONKIN | Not yet recruiting | Villeurbanne | 69626 | France |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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