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

NCT01442246 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: AFU-GETUG 20 - UC-0160/10032010-022037-29
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 35

Brief Summary

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)

Conditions

Metastases

Keywords

Benefit of; adjuvant; treatment; prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Adjuvant treatment

EXPERIMENTAL

Leuproreline acetate

Drug: Leuprorelin Acetate

Surveillance

NO INTERVENTION

Surveillance

Interventions

Leuprorelin Acetate DRUG

Leuprorelin Acetate 45 mg, one injection every 6 months for 24 months

Also known as: Eligard®

Adjuvant treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• UNICANCER: lead
• Astellas Pharma Inc: collaborator

Study Sites (35)

Clinique Victor Pauchet

Amiens, 80000, France

Location

Chu Besancon

Besançon, 25030, France

Location

Chu Bordeaux- Hopital Pellegrin

Bordeaux, 33000, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Chru de Brest

Brest, 29069, France

Location

Hopital Henri Mondor

Créteil, 94010, France

Location

Chu Bocage

Dijon, 21079, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, 85925, France

Location

Chru Lille

Lille, 59037, France

Location

Chu Limoges

Limoges, 87042, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Institut Paoli Calmettes

Marseille, 13009, France

Location

Hopital Nord

Marseille, 13015, France

Location

Clinique Beausoleil

Montpellier, 34070, France

Location

Hopital Lapeyronie

Montpellier, 34295, France

Location

Chu de Nancy

Nancy, 54500, France

Location

Chu Nantes

Nantes, 44093, France

Location

Chu Pasteur

Nice, 06002, France

Location

Chu Caremeau

Nîmes, 30029, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Hopital Cochin

Paris, 75014, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

HEGP

Paris, 75015, France

Location

Hopital Tenon

Paris, 75020, France

Location

Hopital Pitie Salpetriere

Paris, 75651, France

Location

Chu La Miletrie

Poitiers, 86000, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Chu Pontchaillou

Rennes, 35033, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Centre Hopsitalier Prive - Polyclinique Du Littoral

Saint-Brieuc, 22000, France

Location

Clinique Mutualiste

Saint-Etienne, 42013, France

Location

Chu Strasbourg

Strasbourg, 67090, France

Location

Hopitaux Civils de Colmar

Strasbourg, 68024, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Chu Rangueil

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Leuprolide; luprolide acetate gel depot

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• François ROZET, MD

  Montsouris Institute, Paris

  STUDY DIRECTOR

• Stephane Culine, Prof, MD

  Saint-Louis Hospital, Paris, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: September 28, 2011
• Study Start: July 1, 2011
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (35)