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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01442246
Recruitment Status : Recruiting
First Posted : September 28, 2011
Last Update Posted : June 21, 2016
Information provided by (Responsible Party):

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.


  • 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.
Study Start Date : July 2011
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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

Contact: François ROZET, MD 00 33 1 56 61 66 21 franç
Contact: Stéphane CULINE, Prof MD 00 33 1 42 49 42 47

Clinique Victor Pauchet Not yet recruiting
Amiens, France, 80000
Contact: VILLAMIZAR Jorge    03 22 33 71 16   
Chu Besancon Not yet recruiting
Besancon, France, 25030
Contact: KLEINCLAUSS François    03 81 21 88 85   
Chu Bordeaux- Hopital Pellegrin Not yet recruiting
Bordeaux, France, 33000
Contact: ROBERT Grégoire    05 56 79 55 47   
Institut Bergonie Active, not recruiting
Bordeaux, France, 33076
Chru de Brest Not yet recruiting
Brest, France, 29069
Contact: FOURNIER Georges    02 98 34 71 70   
Hopital Henri Mondor Not yet recruiting
Creteil, France, 94010
Contact: SALOMON Laurent    01 49 81 25 53   
Chu Bocage Not yet recruiting
Dijon, France, 21079
Contact: CORMIER Luc    03 80 29 35 80   
Centre Hospitalier Departemental Not yet recruiting
La Roche Sur Yon, France, 85925
Contact: GASCHINARD Nicolas    02 51 44 61 46   
Chru Lille Active, not recruiting
Lille, France, 59037
Chu Limoges Not yet recruiting
Limoges, France, 87042
Contact: DESCAZEAUD Aurélien    05 55 05 88 09   
Hopital Edouard Herriot Active, not recruiting
Lyon, France, 69437
Institut Paoli Calmettes Active, not recruiting
Marseille, France, 13009
Hopital Nord Active, not recruiting
Marseille, France, 13015
Clinique Beausoleil Not yet recruiting
Montpellier, France, 34070
Contact: REBILLARD Xavier    04 67 75 97 70   
Hopital Lapeyronie Not yet recruiting
Montpellier, France, 34295
Contact: THURET Rodolphe    06 82 39 64 69   
Chu de Nancy Not yet recruiting
Nancy, France, 54500
Contact: ESCHWEGE Pascal    03 83 15 31 61   
Chu Nantes Active, not recruiting
Nantes, France, 44093
Chu Pasteur Not yet recruiting
Nice, France, 06002
Contact: QUINTENS Hervé    04 92 03 77 87   
Chu Caremeau Not yet recruiting
Nimes, France, 30029
Contact: DROUPY Stéphane    04 66 68 33 51   
Hopital Saint Louis Not yet recruiting
Paris, France, 75010
Contact: MONGIAT-ARTUS Pierre    01 42 49 96 23   
Hopital Cochin Not yet recruiting
Paris, France, 75014
Contact: PEYROMAURE Michael    01 58 41 41 41   
Institut Mutualiste Montsouris Recruiting
Paris, France, 75014
Contact: ROZET François    01 56 61 66 20   
HEGP Not yet recruiting
Paris, France, 75015
Contact: MEJEAN Arnaud    01 56 09 54 02   
Hopital Tenon Not yet recruiting
Paris, France, 75020
Contact: CUSSENOT Olivier    01 56 01 64 95   
Hopital Pitie Salpetriere Not yet recruiting
Paris, France, 75651
Contact: ROUPRET Morgan    06 60 54 41 66   
Chu La Miletrie Not yet recruiting
Poitiers, France, 86000
Contact: IRANI Jacques    05 49 44 38 44   
Institut Jean Godinot Not yet recruiting
Reims, France, 51056
Contact: NGUYEN Tandat    03 26 50 43 51   
Chu Pontchaillou Active, not recruiting
Rennes, France, 35033
Hopital Charles Nicolle Active, not recruiting
Rouen, France, 76031
Centre Hopsitalier Prive - Polyclinique Du Littoral Active, not recruiting
Saint Brieuc, France, 22000
Clinique Mutualiste Active, not recruiting
Saint Etienne, France, 42013
Chu Strasbourg Active, not recruiting
Strasbourg, France, 67090
Hopitaux Civils de Colmar Not yet recruiting
Strasbourg, France, 68024
Contact: SCHNEIDER Marc    03 89 12 45 20   
Hopital Foch Not yet recruiting
Suresnes, France, 92150
Contact: LEBRET Thierry    01 46 25 24 87   
Chu Rangueil Recruiting
Toulouse, France, 31059
Contact: SOULIE Michel    05 61 32 27 31   
Sponsors and Collaborators
Study Director: François ROZET, MD Montsouris Institute, Paris
Study Chair: Stephane Culine, Prof, MD Saint-Louis Hospital, Paris, France

Responsible Party: UNICANCER Identifier: NCT01442246     History of Changes
Other Study ID Numbers: AFU-GETUG 20/0310
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016

Keywords provided by UNICANCER:
Benefit of

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