E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess prostate-specific antigen (PSA) and testosterone levels after continuous and intermittent androgen deprivation therapy and compare time to PSA progression. |
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E.2.2 | Secondary objectives of the trial |
- 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 |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
At study entry (visit 1): 1. Written informed consent has been obtained 2. Male subjects aged >= 18 and <80 years old 3. Histologically or cytologically confirmed adenocarcinoma of the prostate meeting the following criteria: - Locally advanced (stage T3 or T4) prostate cancer, N0 or N+, M0 with PSA >= 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 =< 1 ng/ml (at least 2 weeks apart) following 6 months of complete androgen suppression |
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E.4 | Principal 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 =< 1.7 mM or 50 ng/dL 12. Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 mmol/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. |
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 3 |