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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001561-32 | EudraCT Number |
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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.
Study the effectiveness of the association of a short duration hormonal therapy by degarelix (Firmagon ®) and radiotherapy, with radiotherapy alone on survival without events in the treatment of detectable PSA after radical prostatectomy.
122 patients should be included over a period of 2 years. Patients will be treated according to the following scheme:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation | Active Comparator | Pelvic radiotherapy
|
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| Radiation and Degarelix | Experimental | Radiotherapy:
Associated with hormonal therapy by degarelix:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug | First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival without biological event | Biochemical recurrence was defined as a PSA > nadir + 0.4 ng / mL confirmed by a second PSA> nadir + 0.4 ng / mL in elevation. | 5 years |
| Survival without clinical event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Igor LATORZEFF | Clinique Pasteur | Principal Investigator |
| Laurent SALOMON | CHU Henri Mondor | Principal Investigator |
| Paul SARGOS | Institut Bergonié | Principal Investigator |
| Emmanuel MEYER | Centre François Baclesse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de l'Ouest -Site Paul Papin | Angers | 49933 | France | |||
| Institut Sainte Catherine |
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| Label | URL |
|---|---|
| Site UNICANCER | View source |
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Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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| Pelvic Radiotherapy | Radiation | 46 Gy in 23 fractions Prostate only-boost up to 66 Gy |
|
The clinical recurrence will be defined by the discovery of a local recurrence in rectal examination, the appearance of metastases by imaging or biopsy, or clinical manifestation associated with malignant disease without elevated PSA but with histological documentation or imaging.
| 5 years |
| Survival without metastases | 5 years |
| Overall survival | 5 years |
| Acute and late toxicities of the association of hormone therapy with radiotherapy | according CTC-AE v4.0 | up to 5 years |
| Toxicities of radiotherapy | according CTC-AE v4.0 | up to 5 years |
| Patient Quality of life | QLQ-C30, QLQ-PR25 and IPSS | up to 5 years after the end of the radiotherapy |
| kinetics of testosterone | up to 12 months after the end of the radiotherapy and after biological release |
| Avignon |
| 84918 |
| France |
| Chu Jean Minjoz | Besançon | 25030 | France |
| Institut Bergonié | Bordeaux | 33076 | France |
| Centre d'oncologie - Clinique Pasteur | Brest | 29200 | France |
| Centre François Baclesse | Caen | 14076 | France |
| Centre hospitalier de Chambéry | Chambéry | 73011 | France |
| Hôpital Henri Mondor | Créteil | 94010 | France |
| Centre d'oncologie et de radiothérapie du Parc | Dijon | 21000 | France |
| Centre Georges François Leclerc | Dijon | 21079 | France |
| Clinique Sainte-Marguerite | Hyères | 83400 | France |
| Chd Vendee | La Roche-sur-Yon | 85925 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Clinique Clairval | Marseille | 13009 | France |
| CHU La Timone - Hôpital Nord | Marseille | 13385 | France |
| Groupe Oncorad Garonne Clinique Du Pont de Chaume | Montauban | 82017 | France |
| Ghi Le Raincy / Montfermeil | Montfermeil | 93370 | France |
| Centre Azureen de Cancerologie | Mougins | 06250 | France |
| Centre Hospitalier Emile Muller | Mulhouse | 68070 | France |
| Institut de Cancerologie de Lorraine | Nancy | 54519 | France |
| Centre Antoine Lacassagne | Nice | 06088 | France |
| Chu Caremeau | Nîmes | 30029 | France |
| CHR Orléans La Source | Orléans | 45000 | France |
| Hôpital d'Instruction des Armées du Val de Grâce | Paris | 75005 | France |
| Hôpital Saint Louis | Paris | 75010 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| CHU de POITIERS | Poitiers | 86021 | France |
| Institut Jean Godinot | Reims | 51056 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Clinique Armoricaine de Radiologie | Saint-Brieuc | 22015 | France |
| CHP Saint Grégoire | Saint-Grégoire | 35760 | France |
| Institut de Cancérologie de l'Ouest René Gauducheau | Saint-Herblain | 44805 | France |
| Clinique Mutualiste de l'Estuaire | Saint-Nazaire | 44606 | France |
| Institut de Cancérologie LUCIEN NEUWIRTH | Saint-Priest-en-Jarez | 42271 | France |
| Clinique Cote Emeraude | St-Malo | 35404 | France |
| Hôpitaux du Léman | Thonon-les-Bains | 74200 | France |
| Groupe Oncorad Garonne | Toulouse | 31076 | France |
| Centre Marie Curie | Valence | 26000 | France |
| GUSTAVE ROUSSY, Cancer Campus, Grand Paris | Villejuif | 94800 | France |
| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
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