Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Multicenter Randomised Phase II Study Comparing the Efficiency of a HT Concomitant With RT vs RT Alone in the Salvage of Patients With a Detectable PSA After Prostatectomy

Conditions
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Adenocarcinoma of Prostate

Intervention / Treatment
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* Drug: Degarelix
* Radiation: Pelvic Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with localized prostate adenocarcinoma treated with radical prostatectomy (whatever the initial prognostic stage) R0 or R1 pN0 or pNx 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 PSA ≤2 ng/mL at moment of the randomisation No clinical signs of progressive disease (bone scan or PET scan or abdominal and pelvic scan or MRI): N0, M0 Neutrophils ≥1500/mm³; platelet count ≥100 000/mm³ Bilirubin ≤ upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) ≤1.5 ULN Creatinine <140 µmol/L (or clearance >60 mL/min) Normal fasting glucose Eastern Cooperative Oncology Group (ECOG) ≤1 Age >18 years Life expectancy ≥10 years Patients with invasive cancer in complete response for more than five years are eligible Patients who have received the information sheet and signed the informed consent form Patients with a public or a private health insurance coverage Exclusion Criteria: Prostate cancer histology other than adenocarcinoma Patients pN1, N1 and M1 History of pelvic radiotherapy Contraindication to pelvic irradiation (eg, scleroderma, chronic inflammatory bowel disease, etc.) Testosterone ≤0.5 ng/mL History of surgical castration Previous treatment by hormonotherapy Antineoplastic treatment in progress History of another invasive cancer within 5 years before inclusion (with the exception of a basal cell skin carcinoma treated) Known pituitary adenoma Severe hypertension uncontrolled by appropriate treatment (160 mm Hg systolic and/or 90 mm Hg diastolic) Patient with a corrected QT interval (using Fridericia correction) greater than 450 msec Individual deprived of liberty or placed under the authority of a tutor Unable to undergo medical monitoring test for geographical, social or psychological reasons Known hypersensitivity to the treatment in test 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiation<br>Pelvic radiotherapy 46 Gy in 23 fractions of 2 Gy. prostate only-boost up to 66 Gy | Radiation: Pelvic Radiotherapy<br>* 46 Gy in 23 fractions Prostate only-boost up to 66 Gy<br>|
| Experimental: Radiation and Degarelix<br>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 | Drug: Degarelix<br>* First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)<br>* Other names: Firmagon;Radiation: Pelvic Radiotherapy<br>* 46 Gy in 23 fractions Prostate only-boost up to 66 Gy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate-Specific Antigen, LHRH antagonist, Radiotherapy