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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by UNICANCER
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01442246
First received: September 27, 2011
Last updated: June 20, 2016
Last verified: June 2016
  Purpose

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 Intervention Phase
Metastases
Drug: Leuprorelin Acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: July 2011
Estimated Study Completion Date: January 2023
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442246

Contacts
Contact: François ROZET, MD 00 33 1 56 61 66 21 françois.rozet@imm.fr
Contact: Stéphane CULINE, Prof MD 00 33 1 42 49 42 47 stephane.culine@sls.aphp.fr

Locations
France
Clinique Victor Pauchet Not yet recruiting
Amiens, France, 80000
Contact: VILLAMIZAR Jorge    03 22 33 71 16    jorge.villamizar@clinique-pauchet.fr   
Chu Besancon Not yet recruiting
Besancon, France, 25030
Contact: KLEINCLAUSS François    03 81 21 88 85    francois.kleinclauss@univ-fcomte.fr   
Chu Bordeaux- Hopital Pellegrin Not yet recruiting
Bordeaux, France, 33000
Contact: ROBERT Grégoire    05 56 79 55 47    gregoire.robert@chu-bordeaux.fr   
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    georges.fournier@chu-brest.fr   
Hopital Henri Mondor Not yet recruiting
Creteil, France, 94010
Contact: SALOMON Laurent    01 49 81 25 53    laurent.solomon@hmn.aphp.fr   
Chu Bocage Not yet recruiting
Dijon, France, 21079
Contact: CORMIER Luc    03 80 29 35 80    luc.cormier@chu-dijon.fr   
Centre Hospitalier Departemental Not yet recruiting
La Roche Sur Yon, France, 85925
Contact: GASCHINARD Nicolas    02 51 44 61 46    nicolas.gaschinard@wanadoo.fr   
Chru Lille Active, not recruiting
Lille, France, 59037
Chu Limoges Not yet recruiting
Limoges, France, 87042
Contact: DESCAZEAUD Aurélien    05 55 05 88 09    aurelien.descazeaud@chu-limoges.fr   
Hopital Edouard Herriot Active, not recruiting
Lyon, France, 69437
Hopital Nord Active, not recruiting
Marseille, France, 13015
Institut Paoli Calmettes Active, not recruiting
Marseille, France, 13009
Clinique Beausoleil Not yet recruiting
Montpellier, France, 34070
Contact: REBILLARD Xavier    04 67 75 97 70    xavier.rebillard@wanadoo.fr   
Hopital Lapeyronie Not yet recruiting
Montpellier, France, 34295
Contact: THURET Rodolphe    06 82 39 64 69    rodolphethuret@yahoo.fr   
Chu de Nancy Not yet recruiting
Nancy, France, 54500
Contact: ESCHWEGE Pascal    03 83 15 31 61    p.eschwege@chu-nancy.fr   
Chu Nantes Active, not recruiting
Nantes, France, 44093
Chu Pasteur Not yet recruiting
Nice, France, 06002
Contact: QUINTENS Hervé    04 92 03 77 87    quintens.h@orange.fr   
Chu Caremeau Not yet recruiting
Nimes, France, 30029
Contact: DROUPY Stéphane    04 66 68 33 51    stephane.droupy@chu-nimes.fr   
Hopital Saint Louis Not yet recruiting
Paris, France, 75010
Contact: MONGIAT-ARTUS Pierre    01 42 49 96 23    pierre.mongiat-artus@sls.aphp.fr   
Hopital Cochin Not yet recruiting
Paris, France, 75014
Contact: PEYROMAURE Michael    01 58 41 41 41    michael.peyromaure@cch.aphp.fr   
Institut Mutualiste Montsouris Recruiting
Paris, France, 75014
Contact: ROZET François    01 56 61 66 20    francois.rozet@imm.fr   
HEGP Not yet recruiting
Paris, France, 75015
Contact: MEJEAN Arnaud    01 56 09 54 02    arnaud.mejean@egp.aphp.fr   
Hopital Tenon Not yet recruiting
Paris, France, 75020
Contact: CUSSENOT Olivier    01 56 01 64 95    olivier.cussenot@tnn.aphp.fr   
Hopital Pitie Salpetriere Not yet recruiting
Paris, France, 75651
Contact: ROUPRET Morgan    06 60 54 41 66    mroupret@gmail.com   
Chu La Miletrie Not yet recruiting
Poitiers, France, 86000
Contact: IRANI Jacques    05 49 44 38 44    j.irani@chu-poitiers.fr   
Institut Jean Godinot Not yet recruiting
Reims, France, 51056
Contact: NGUYEN Tandat    03 26 50 43 51    tandatnguyen@reims.unicancer.fr   
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    schneidermarc1@gmail.com   
Hopital Foch Not yet recruiting
Suresnes, France, 92150
Contact: LEBRET Thierry    01 46 25 24 87    t.lebret@hopital-foch.org   
Chu Rangueil Recruiting
Toulouse, France, 31059
Contact: SOULIE Michel    05 61 32 27 31    soulie.m@chu-toulouse.fr   
Sponsors and Collaborators
UNICANCER
Investigators
Study Director: François ROZET, MD Montsouris Institute, Paris
Study Chair: Stephane Culine, Prof, MD Saint-Louis Hospital, Paris, France
  More Information

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01442246     History of Changes
Other Study ID Numbers: AFU-GETUG 20/0310 
Study First Received: September 27, 2011
Last Updated: June 20, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on July 26, 2016