DRUG
Degarelix
First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)
Status
Active, not recruiting
Phase
Phase 2
Enrollment
120
Locations
39
Results
Not posted
Publications
0
Study summary
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: * 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
Interventions
DRUG
First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)
RADIATION
46 Gy in 23 fractions Prostate only-boost up to 66 Gy
Timeline
First posted
Nov 25, 2013
Study start
Dec 2012
Primary completion
Mar 2022
Study completion
Mar 2025
Results posted
Not reported
Registry updated
Dec 16, 2024
Outcomes
The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival
Time frame · 5 years
Survival without biological event
Time frame · 5 years
Biochemical recurrence was defined as a PSA \> nadir + 0.4 ng / mL confirmed by a second PSA\> nadir + 0.4 ng / mL in elevation.
Survival without clinical event
Time frame · 5 years
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.
Survival without metastases
Time frame · 5 years
Overall survival
Time frame · 5 years
Acute and late toxicities of the association of hormone therapy with radiotherapy
Time frame · up to 5 years
according CTC-AE v4.0
Toxicities of radiotherapy
Time frame · up to 5 years
according CTC-AE v4.0
Patient Quality of life
Time frame · up to 5 years after the end of the radiotherapy
QLQ-C30, QLQ-PR25 and IPSS
kinetics of testosterone
Time frame · up to 12 months after the end of the radiotherapy and after biological release
Eligibility
Inclusion Criteria: 1. Patient with localized prostate adenocarcinoma treated with radical prostatectomy (whatever the initial prognostic stage) 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: 1. Prostate cancer histology other than adenocarcinoma 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
Study locations
France. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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