E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 study whether treatment with degarelix may stabilise or reverse PSA progression in patients with prostate cancer after failure of GnRH agonist treatment [ Time Frame: After 3 months treatment ] [ Designated as safety issue: Yes ]
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E.2.2 | Secondary objectives of the trial |
To investigate testosterone control [ Time Frame: From visit 2-14, equal to 12 months treatment ] [ Designated as safety issue: No ]
To investigate LH/FSH control [ Time Frame: From visit 2-14, equal to 12 months treatment ] [ Designated as safety issue: No ]
To investigate PSA progression-free survival [ Time Frame: From visit 2-14, equal to 12 months treatment ] [ Designated as safety issue: No ]
To investigate overall survival [ Time Frame: From date of informed consent - visit 14 ] [ Designated as safety issue: Yes ]
To investigate drug safety of degarelix [ Time Frame: Collection of all AEs and SAEs and follow-up with patients until they are recovered or their condition is stable. After the end of trial only AEs that are serious or related to IMP will be followed. ] [ Designated as safety issue: Yes ]
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient has given written informed consent before any trial-related activity is performed. 2. Patient is 18 years or older. 3. Histologically confirmed prostate cancer. 4. Patient has received GnRH receptor agonist therapy for a duration of at least 12 months (the first dose of GnRH-antagonist is to be administered when the next dose of the GnRH-agonist would have been due). 5. Patient has experienced rising PSA levels although receiving GnRH agonist therapy, defined as two consecutive rises of PSA at least two weeks apart in two 50% increases over the nadir, and at least one PSA value of >2.5 ng/mL within the last six months. 6. Testosterone ≥0.32 ng/mL at inclusion 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 8. Estimated life expectancy at least 12 months. |
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E.4 | Principal exclusion criteria |
1. Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years. 2. Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been received before Visit 1). 3. Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA increase as described as above and before trial entry. Antiandrogens as part of complete androgen blockade must have been discontinued at least three months before first dose of trial medication. 4. Previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer. 5. Known hypersensitivity towards any component of the investigational medical product. 6. History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema. 7. Known or suspected clinically significant liver and/or biliary disease. 8. Any clinically significant laboratory abnormalities, disorders, or other condition, including alcohol or drug abuse, which may affect the patient's health or the outcome of the trial as judged by the Investigator. 9. Patient has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator. 10. Patient has a mental incapacity or language barriers precluding adequate understanding or co-operation. 11. Patient has received an investigational drug within the last 28 days preceding screening visit. Or longer if considered to possibly influencing the outcome of the current trial. 12. Previous participation in any degarelix trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
To study whether treatment with degarelix may stabilise or reverse PSA progression in patients with prostate cancer after failure of GnRH agonist treatment [ Time Frame: After 3 months treatment ] [ Designated as safety issue: Yes ] |
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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 | No |
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 | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |