E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | pr t |
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 demonstrate that the efficacy in achieving and maintaining testosterone castration levels (<=0.5 ng/mL) in prostate cancer patients treated up to either 12 or 13 months is at least 80%. |
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E.2.2 | Secondary objectives of the trial |
•To compare the overall testosterone response up to either 12 or 13 months of treatment. •To compare the PSA response up to either 12 or 13 months of treatment. •To compare the time to disease progression (PSA progression, death from any cause, introduction of additional therapy related to the prostate cancer). •To evaluate safety and tolerability profiles. •To evaluate pharmacokinetic (degarelix) and pharmacodynamic (testosterone) response. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
•Has given written consent before any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient. •Has a histologically confirmed (Gleason graded) adenocarcinoma of prostate (all stages) in whom endocrine treatment, except for neoadjuvant hormonal therapy, is indicated. This includes patients with rising PSA after having undergone prostatectomy or radiotherapy with curative intention. •Is a male patient aged 18 years or over. •Has a baseline serum testosterone level above the lower limit of normal range. •Has an ECOG score of <=2. •Has a PSA value of >=2 ng/mL. •Has a life expectancy of at least 13 months. |
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E.4 | Principal exclusion criteria |
•Has had previous or is currently under hormonal management of prostate cancer •Is considered to be a candidate for curative therapy within 13 months from Screening Visit •Has a history of, or predisposition to, severe hypersensitivity reactions such as severe asthma, anaphylactic reactions, or chronic or recurrent urticaria and/or angioedema •Has hypersensitivity towards any component of the investigational medicinal product •Has had a cancer disease within the last 5 years except from prostate cancer and surgically removed basal or squamous cell carcinoma of the skin •Has a known or suspected hepatic or symptomatic biliary disease •Has elevated serum ALT level above upper level of normal range or serum toltal bilirubin level above upper level of normal range at the Screening Visit •Has other clinically significant laboratory abnormalities, which in the judgement of the investigator would interfere with the patient's participation in this study or evaluation of study results •Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with study participation or which may affect the conclusion of the study as judged by the investigator •Has a mental incapacity or language barriers precluding adequate understanding or co-operation. •Has received an investigational drug within the last 28 days preceeding Screening Visit or longer if considered by the investigator to possibly influence the outcome of the current study •Has previously participated in any degarelix study |
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E.5 End points |
E.5.1 | Primary end point(s) |
•Proportion of patients with testosterone level <=0.5 ng/mL from Day 28 until end of study
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 2 |
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 | 2 |