Benefit Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.
This study is ongoing, but not recruiting participants.
Sponsor:
UNICANCER
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01442246
First received: September 27, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
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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 ((Eligard® ) Other: Reference arm |
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: | June 2011 |
| Estimated Study Completion Date: | January 2023 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Adjuvant treatment |
Drug: Leuprorelin Acetate ((Eligard® )
Leuprorelin Acetate 45mg, one injection every 6 months for 24 months
|
| No Intervention: Surveillance |
Other: Reference arm
Reference arm is only a surveillance
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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 with postoperative Gleason score > 7, or ≥ 7 with the presence of high-grade Gleason patterns (5) and R0, N0 or Nx , M0 or Patients pT3b, R0, N0 or Nx , M0 whatever the Gleason score
- Postoperative PSA < 0.1 ng/mL (dosage perform within 2 months after surgery)
- Neutrophils ≥ 1500/mm3, platelets ≥ 100 000/mm3
- 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)
- Patients affiliated to a social security scheme
Exclusion Criteria:
- Previous treatments for prostatic adenocarcinoma (HT or orchyectomy 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 | |
| Hopital Nord | |
| Marseille, France, 13015 | |
| Institut Paoli Calmettes | |
| Marseille, France, 13009 | |
| 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 Tenon | |
| Paris, France, 75020 | |
| Institut Mutualiste Montsouris | |
| Paris, France, 75014 | |
| Hopital Pitie Salpetriere | |
| Paris, France, 75651 | |
| Hopital Cochin | |
| Paris, France, 75014 | |
| HEGP | |
| Paris, France, 75015 | |
| Hopital Saint Louis | |
| Paris, France, 75010 | |
| 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 | |
| Hopitaux Civils de Colmar | |
| Strasbourg, France, 68024 | |
| Chu Strasbourg | |
| Strasbourg, France, 67090 | |
| Hopital Foch | |
| Suresnes, France, 92150 | |
| Chu Rangueil | |
| Toulouse, France, 31059 | |
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
No publications provided
| 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: | September 27, 2011 |
| Health Authority: | France: Agence Française de Sécurité Sanitaire des Produits de Santé |
Keywords provided by UNICANCER:
|
Benefit of adjuvant treatment prostatectomy |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Recurrence Neoplastic Processes Neoplasms Pathologic Processes Disease Attributes Adjuvants, Immunologic Leuprolide Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Fertility Agents, Female Fertility Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 19, 2013