Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.

Study Overview
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Brief Summary
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PRINCIPAL OBJECTIVE: Evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy in patients with high risk of recurrence. SECONDARY OBJECTIVE(S): PSA evolution Evaluation of testosterone level Specific survival Overall survival Tolerance Quality of life (QLQ-C30 questionnaires)

Official Title
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Phase III Randomised Trial to Evaluate the Benefit of Adjuvant Hormonal Treatment With Leuprorelin Acetate (Eligard® 45 mg) for 24 Months After Radical Prostatectomy in Patients With High Risk of Recurrence.

Conditions
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Metastases

Intervention / Treatment
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* Drug: Leuprorelin Acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have received the information leaflet and signed the consent form ≥18 years of age with a life expectancy of at least 10 years Performance Status (ECOG) ≤2 Radical prostatectomy (RP) with or without extended pelvic lymphadenectomy in the 3 months preceding inclusion Histologically confirmed prostatic adenocarcinoma Patients R0, N0 or Nx or N+ (≤ 2 nodes among nodes removed), M0 and with at least one of the following criteria: postoperative Gleason score >7 postoperative Gleason score =7 with the presence of high-grade Gleason patterns pT3b patients Postoperative PSA <0.1 ng/mL (dosage perform within 2 months after surgery) Neutrophils ≥1500/mm³, platelets ≥100000/mm³ Bilirubin ≤ upper normal limit (this will not apply to subjects with Gilbert's syndrome, persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology); ASAT and ALAT ≤1.5 times upper normal limit; Creatinine <140 µmol/l (or clearance >60 mL/min) Patients affiliated to a social security scheme Exclusion Criteria: Previous treatments for prostatic adenocarcinoma (HT or orchiectomy or CT) Presence of metastases: positive bone scintigraphy, including Patients with medullary compression and/or abdominal-pelvic CT scan or MRI showing lymph node and/or visceral involvement History of cancer, with the exception of basal cell carcinoma or any other cancer treated in the 5 years before inclusion and in complete remission Incompatible concomitant treatment(s) Hypersensitivity to other GnRH agonists and/or any of the excipients of Eligard® Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial Persons deprived of their freedom or under supervision (including guardianship), Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days

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 |
| --- | --- |
| Experimental: Adjuvant treatment<br>Leuproreline acetate | Drug: Leuprorelin Acetate<br>* Leuprorelin Acetate 45 mg, one injection every 6 months for 24 months<br>* Other names: Eligard®;|
| No Intervention: Surveillance<br>Surveillance | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The principal criterion is the evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy. |  | The principal criterion will be evaluated 12 years after the inclusion of the first patient. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benefit of, adjuvant, treatment, prostatectomy