Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy
NCT ID: NCT01994239
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2012-12-31
2025-03-31
Brief Summary
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Detailed Description
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122 patients should be included over a period of 2 years. Patients will be treated according to the following scheme:
* Arm A (61 patients) : Pelvic Radiotherapy: 46 Gy and prostate only boost up to 66 Gy
* Arm B (61 patients) : Arm A + hormonal therapy by degarelix during 6 months
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiation
Pelvic radiotherapy
* 46 Gy in 23 fractions of 2 Gy.
* prostate only-boost up to 66 Gy
Pelvic Radiotherapy
46 Gy in 23 fractions Prostate only-boost up to 66 Gy
Radiation and Degarelix
Radiotherapy:
* 46 Gy in 23 fractions of 2 Gy.
* prostate only-boost up to 66 Gy
Associated with hormonal therapy by degarelix:
* beginning in parallel to radiotherapy for 6 months
* First dose of 240 mg
* Maintenance dose of 80 mg
Degarelix
First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)
Pelvic Radiotherapy
46 Gy in 23 fractions Prostate only-boost up to 66 Gy
Interventions
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Degarelix
First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)
Pelvic Radiotherapy
46 Gy in 23 fractions Prostate only-boost up to 66 Gy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. R0 or R1
3. pN0 or pNx
4. Post prostatectomy PSA ≥0.2 ng/mL measured between 1 month and 4 months after surgery and increasing to a second test performed between 1 et 8 months after the post prostatectomy dosage
5. PSA ≤2 ng/mL at moment of the randomisation
6. No clinical signs of progressive disease (bone scan or PET scan or abdominal and pelvic scan or MRI): N0, M0
7. Neutrophils ≥1500/mm³; platelet count ≥100 000/mm³
8. Bilirubin ≤ upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) ≤1.5 ULN
9. Creatinine \<140 µmol/L (or clearance \>60 mL/min)
10. Normal fasting glucose
11. Eastern Cooperative Oncology Group (ECOG) ≤1
12. Age \>18 years
13. Life expectancy ≥10 years
14. Patients with invasive cancer in complete response for more than five years are eligible
15. Patients who have received the information sheet and signed the informed consent form
16. Patients with a public or a private health insurance coverage
Exclusion Criteria
2. Patients pN1, N1 and M1
3. History of pelvic radiotherapy
4. Contraindication to pelvic irradiation (eg, scleroderma, chronic inflammatory bowel disease, etc.)
5. Testosterone ≤0.5 ng/mL
6. History of surgical castration
7. Previous treatment by hormonotherapy
8. Antineoplastic treatment in progress
9. History of another invasive cancer within 5 years before inclusion (with the exception of a basal cell skin carcinoma treated)
10. Known pituitary adenoma
11. Severe hypertension uncontrolled by appropriate treatment (160 mm Hg systolic and/or 90 mm Hg diastolic)
12. Patient with a corrected QT interval (using Fridericia correction) greater than 450 msec
13. Individual deprived of liberty or placed under the authority of a tutor
14. Unable to undergo medical monitoring test for geographical, social or psychological reasons
15. Known hypersensitivity to the treatment in test
16. Administration of an investigational therapeutic within 28 days prior to the screening visit or more if treatment is likely to influence the outcome of this
18 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Igor LATORZEFF
Role: PRINCIPAL_INVESTIGATOR
Clinique Pasteur
Laurent SALOMON
Role: PRINCIPAL_INVESTIGATOR
CHU Henri Mondor
Paul SARGOS
Role: PRINCIPAL_INVESTIGATOR
Institut Bergonié
Emmanuel MEYER
Role: PRINCIPAL_INVESTIGATOR
Centre François Baclesse
Locations
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Institut de Cancérologie de l'Ouest -Site Paul Papin
Angers, , France
Institut Sainte Catherine
Avignon, , France
Chu Jean Minjoz
Besançon, , France
Institut Bergonié
Bordeaux, , France
Centre d'oncologie - Clinique Pasteur
Brest, , France
Centre François Baclesse
Caen, , France
Centre hospitalier de Chambéry
Chambéry, , France
Hôpital Henri Mondor
Créteil, , France
Centre d'oncologie et de radiothérapie du Parc
Dijon, , France
Centre Georges François Leclerc
Dijon, , France
Clinique Sainte-Marguerite
Hyères, , France
Chd Vendee
La Roche-sur-Yon, , France
Centre Leon Berard
Lyon, , France
Clinique Clairval
Marseille, , France
CHU La Timone - Hôpital Nord
Marseille, , France
Groupe Oncorad Garonne Clinique Du Pont de Chaume
Montauban, , France
Ghi Le Raincy / Montfermeil
Montfermeil, , France
Centre Azureen de Cancerologie
Mougins, , France
Centre Hospitalier Emile Muller
Mulhouse, , France
Institut de Cancerologie de Lorraine
Nancy, , France
Centre Antoine Lacassagne
Nice, , France
Chu Caremeau
Nîmes, , France
CHR Orléans La Source
Orléans, , France
Hôpital d'Instruction des Armées du Val de Grâce
Paris, , France
Hôpital Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de POITIERS
Poitiers, , France
Institut Jean Godinot
Reims, , France
Centre Henri Becquerel
Rouen, , France
Clinique Armoricaine de Radiologie
Saint-Brieuc, , France
CHP Saint Grégoire
Saint-Grégoire, , France
Institut de Cancérologie de l'Ouest René Gauducheau
Saint-Herblain, , France
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, , France
Institut de Cancérologie LUCIEN NEUWIRTH
Saint-Priest-en-Jarez, , France
Clinique Cote Emeraude
St-Malo, , France
Hôpitaux du Léman
Thonon-les-Bains, , France
Groupe Oncorad Garonne
Toulouse, , France
Centre Marie Curie
Valence, , France
GUSTAVE ROUSSY, Cancer Campus, Grand Paris
Villejuif, , France
Countries
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Related Links
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Site UNICANCER
Other Identifiers
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2012-001561-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UC-0160/1204
Identifier Type: -
Identifier Source: org_study_id