Adenocarcinoma of Prostate
Conditions
Keywords
Prostate-Specific Antigen, LHRH antagonist, Radiotherapy
Brief 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.
Detailed description
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
DRUGDegarelix
First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)
RADIATIONPelvic Radiotherapy
46 Gy in 23 fractions Prostate only-boost up to 66 Gy
Sponsors
Ferring Pharmaceuticals
UNICANCER
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival without clinical event | 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 | 5 years | — |
| Overall survival | 5 years | — |
| Survival without biological event | 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. |
| Toxicities of radiotherapy | up to 5 years | according CTC-AE v4.0 |
| Patient Quality of life | up to 5 years after the end of the radiotherapy | QLQ-C30, QLQ-PR25 and IPSS |
| kinetics of testosterone | up to 12 months after the end of the radiotherapy and after biological release | — |
| Acute and late toxicities of the association of hormone therapy with radiotherapy | up to 5 years | according CTC-AE v4.0 |
Countries
France
Outcome results
None listed