Histologically or cytologically confirmed adenocarcinoma of the prostate (PCa) meeting the following criteria: - Locally adv. (stage T3 or T4) PCa, N0 or N+, M0 with PSA >= 5 ng/ml, or - Relapsing PCa following radical prostatectomy for clinically localized PCa with a serum PSA of >= 0.4 ng/ml or, - Relapsing PCa following radiotherapy with a serum PSA of >= 1 ng/ml as compared to a previous reference value. MedDRA version: 8.0 Level: LLT Classification code 10060862
Conditions
Interventions
Product Name: Eligard 22.5 mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: leuprorelinum
CAS Number: 74381-53-6
Other descriptive name: leuprolide
Concentrat
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: At study entry (visit 1): 1. Written informed consent has been obtained 2. Male subjects aged >= 18 and = 5 ng/ml, or - Relapsing prostate cancer following radical prostatectomy for clinically localized PCa with a serum PSA of >= 0.4 ng/ml that has risen on three successive occasions (values drawn at least 2 weeks apart) as compared to a previous reference value or, - Relapsing prostate cancer following radiotherapy with a serum PSA of >= 1 ng/ml that has risen on three successive occasions (values drawn at least 2 weeks apart) as compared to a previous reference value. 4. Gleason score of >= 6 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 6. Life expectancy of at least 5 years At randomization (visit 4): 7. Two successive decreasing serum PSA levels ==65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At study entry (visit 1): 1. Any suspected second primary tumors, including evidence from special stains (e.g. Prostatic acid phosphatase) 2. Evidence of metastatic disease on bone scintigraphy or CT scan (bone scintigraphy or CT scan from within 6 months of V1 is acceptable) 3. Other malignancy within the last 5 years except; - Adequately treated basal cell or squamous cell skin cancer - Adequately treated other superficial cancer 4. Subjects with acute spinal cord compression, uni- or bilateral ureteric obstruction 5. Any concurrent biological response modifier therapy 6. Concurrent chemotherapy 7. Less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a duration of more than 4 months (single or combination therapy is allowed) 8. Less than 6 months since prior 5-alpha reductase inhibitor treatment for prostate cancer and BPH. 9. Other concurrent hormonal therapy (progesterone preparations for the treatment of subjects presenting with hot flushes are permitted) 10. Any concurrent radiotherapy 11. Testosterone at baseline =150 micro mol/L, AST or ALT > 2x upper limit of normal range (ULN), g-GT > 3x ULN and/or abnormal clinically significant serum total bilirubin (as assessed at visit 1 lab sampling) 13. Subjects with hypersensitivity to GnRH or other GnRH analogues or leuprorelin acetate or any of the excipients of ELIGARD 22.5 mg 14. Subjects with hypersensitivity to CASODEX 50 mg or any of the excipients. 15. Any clinical condition, which in the opinion of the investigator would not allow safe completion of the study. 16. Participation in any clinical study within 3 months, or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess prostate-specific antigen (PSA) and testosterone levels after continuous and intermittent androgen deprivation therapy and compare time to PSA progression.;Secondary Objective: - To compare the overall survival of subjects with relapsing and locally advanced prostate cancer responsive to androgen-deprivation therapy (ADT) treated with intermittent vs. continuous ADT - To compare the effects of these treatment regimens on impotence, libido and vitality/fatigue as well as the physical and emotional well-being of these subjects - To compare general symptoms, role functioning, global perception of quality of life and social functioning of subjects treated with these regimens - To measure and compare bone turnover and exploratory biochemical/prognostic markers for disease progression in subjects treated with these regimens;Primary end point(s): Time to PSA progression, defined as ‘three consecutive increasing PSA values >= 4 ng/mL’ – modified ASTRO definition Based on the ASTRO definition, the date of PSA progression is the mid-point between the PSA nadir during or after the induction period and the first of three increasing PSA values >= 4 ng/mL. Time to progression is calculated from the date of randomization. The confirmatory PSA measurements (second & third) should be performed at the next routine study visits. | — |
Countries
Austria, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed