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

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ClinicalTrials.gov Identifier: NCT01442246
Recruitment Status : Active, not recruiting
First Posted : September 28, 2011
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
UNICANCER

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)

Condition or disease Intervention/treatment Phase
Metastases Drug: Leuprorelin Acetate Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : July 2011
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adjuvant treatment
Leuproreline acetate
Drug: Leuprorelin Acetate
Leuprorelin Acetate 45mg, one injection every 6 months for 24 months
Other Name: Eligard®

No Intervention: Surveillance
Surveillance



Primary Outcome Measures :
  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. [ Time Frame: The principal criterion will be evaluated 12 years after the inclusion of the first patient. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who have received the information leaflet and signed the consent form
  2. ≥ 18 years of age with a life expectancy of at least 10 years
  3. Performance Status (ECOG) ≤ 2
  4. Radical prostatectomy (RP) with or without extended pelvic lymphadenectomy in the 3 months preceding inclusion
  5. Histologically confirmed prostatic adenocarcinoma 6.6. 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 (5);
    • pT3b patients.

7.Postoperative PSA < 0.1 ng/mL (dosage perform within 2 months after surgery) 8.Neutrophils ≥ 1500/mm3, platelets ≥ 100000/mm3 9.Bilirubin ≤ upper normal limit (this will not apply to subjects with Gilbert's syndrome, persistent or recurrent hyperbilirubinemia that is predominantly uncongugated 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 > 60mL/min) 10.Patients affiliated to a social security scheme

Exclusion Criteria:

  1. Previous treatments for prostatic adenocarcinoma (HT or orchyectomy or CT)
  2. 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.
  3. 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.
  4. Incompatible concomitant treatment(s)
  5. Hypersensitivity to other GnRH agonists and/or any of the excipients of Eligard®
  6. Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial
  7. Persons deprived of their freedom or under supervision (including guardianship),
  8. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days.

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442246


Locations
France
Clinique Victor Pauchet
Amiens, France, 80000
Chu Besancon
Besancon, France, 25030
Chu Bordeaux- Hopital Pellegrin
Bordeaux, France, 33000
Institut Bergonie
Bordeaux, France, 33076
Chru de Brest
Brest, France, 29069
Hopital Henri Mondor
Creteil, France, 94010
Chu Bocage
Dijon, France, 21079
Centre Hospitalier Departemental
La Roche Sur Yon, France, 85925
Chru Lille
Lille, France, 59037
Chu Limoges
Limoges, France, 87042
Hopital Edouard Herriot
Lyon, France, 69437
Institut Paoli Calmettes
Marseille, France, 13009
Hopital Nord
Marseille, France, 13015
Clinique Beausoleil
Montpellier, France, 34070
Hopital Lapeyronie
Montpellier, France, 34295
Chu de Nancy
Nancy, France, 54500
Chu Nantes
Nantes, France, 44093
Chu Pasteur
Nice, France, 06002
Chu Caremeau
Nimes, France, 30029
Hopital Saint Louis
Paris, France, 75010
Hopital Cochin
Paris, France, 75014
Institut Mutualiste Montsouris
Paris, France, 75014
HEGP
Paris, France, 75015
Hopital Tenon
Paris, France, 75020
Hopital Pitie Salpetriere
Paris, France, 75651
Chu La Miletrie
Poitiers, France, 86000
Institut Jean Godinot
Reims, France, 51056
Chu Pontchaillou
Rennes, France, 35033
Hopital Charles Nicolle
Rouen, France, 76031
Centre Hopsitalier Prive - Polyclinique Du Littoral
Saint Brieuc, France, 22000
Clinique Mutualiste
Saint Etienne, France, 42013
Chu Strasbourg
Strasbourg, France, 67090
Hopitaux Civils de Colmar
Strasbourg, France, 68024
Hopital Foch
Suresnes, France, 92150
Chu Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
UNICANCER
Astellas Pharma Inc
Investigators
Study Director: François ROZET, MD Montsouris Institute, Paris
Study Chair: Stephane Culine, Prof, MD Saint-Louis Hospital, Paris, France

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01442246     History of Changes
Other Study ID Numbers: AFU-GETUG 20 - UC-0160/1003
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

Keywords provided by UNICANCER:
Benefit of
adjuvant
treatment
prostatectomy

Additional relevant MeSH terms:
Recurrence
Disease Attributes
Pathologic Processes
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents