PROSTATIC ADENOCARCINOMA WITH HIGH RISK OF RECURRENCE. MedDRA version: 18.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ELIGARD 45 mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: leuprolide acetate
CAS Number: 53714-56-0
Concentration unit: mg milligram(s)
Concent
Sponsors
UNICANCER
Eligibility
Sex/Gender
Male
Inclusion 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. 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 7. Postoperative PSA 60mL/min) 10. Patients affiliated to a social security scheme Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - PSA evolution - Evaluation of testosterone level - Specific survival - Overall survival - Tolerance - Quality of life (QLQ-C30 questionnaires);Main 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.;Timepoint(s) of evaluation of this end point: _;Primary end point(s): 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. In case of biological reccurence, the presence of metastases will be evaluated with an abdominal-pelvic CT scan (or MRI) and bone scintigraphy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluation of PSA progression - Evaluation of testosterone level - Evaluation of specific survival - Evaluation of overall survival - Evaluation of tolerance to the treatment - Evaluation of quality of life (QLQ-C30 questionnaires);Timepoint(s) of evaluation of this end point: _ | — |
Countries
France, Germany, Slovakia
Contacts
Public ContactMuriel HABIBIAN, project leader
UNICANCER
Outcome results
None listed