E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
prostate cancer |
Prostata-Karzinom |
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E.1.1.1 | Medical condition in easily understood language |
prostate cancer |
Prostatakrebs |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 investigate the efficacy of goserelin 3.6 mg implant (when applied every 28 days for 56 days) in suppression of testosterone levels below castrate level (0.5 ng/ml). The study will be considered a successful bridging study, if the response rate, i.e., the percentage of patients with plasma testosterone levels below castrate level (0.5 ng/ml) on Days 28 and 56 (at Visits 4 and 6), will be at least 90% in the patients of the modified full analysis set (see Primary efficacy endpoint). • To demonstrate correct functionality of the application system, as assessed by an increase of plasma goserelin levels to a value above the Lower Limit of Quantification (LLOQ) (i.e., presence of goserelin in plasma) and as assessed by the investigator with confirmation by a witness.
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E.2.2 | Secondary objectives of the trial |
No secondary objectives defined.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Males aged 18 years or older • Histologically confirmed diagnosis of carcinoma of the prostate suitable for hormonal manipulation including patients with rising prostate-specific antigen (PSA) after having undergone surgery or radiotherapy with curative intention • Normal testosterone value (> 10.4 nmol/l or > 3 ng/ml) at screening, according to immunoassay • Life expectancy of at least six months • The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form • The patient is able to understand and follow instructions and is able to participate in the study for the entire study period • Patient has given his written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures.
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E.4 | Principal exclusion criteria |
• Hypersensitivity to Zoladex (registered trademark) or to other GnRH analogues • Treatment with GnRH analogues, completed less than 6 months prior to the baseline visit • Patients considered being candidates for curative therapy i.e. radical prostatectomy or radiotherapy within 6 months from inclusion • Cancer disease within the last 5 years except prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin • Patients with clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or any infectious disorder or any other condition including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator • Mental incapacity or language barriers precluding adequate understanding or co-operation • Previous participation in this study • Simultaneous or less than 12 weeks earlier participation in another clinical trial • Known allergy against one of the ingredients in the test preparation
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy endpoint: The response rate, defined as the percentage of patients with plasma testosterone levels below castrate level (0.5 ng/ml) at the end of the first treatment cycle (Visit 4, Day 28) and at the end of the second treatment cycle (Visit 6, Day 56) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Testosterone plasma levels measured by LC-MS/MS at visits day 28 and 56 |
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E.5.2 | Secondary end point(s) |
Secondary Efficacy Endpoints: • Percentage of patients with an increase in plasma goserelin levels at Visit 3 (Day 14) and Visit 5 (Day 42) to a value above LLOQ (i.e., presence of goserelin in plasma), • Percentage of applications with correct functionality of the application system, • Percentage of patients with an increase in plasma goserelin at Visit 3 (Day 14) to a value above LLOQ (i.e., presence of goserelin in plasma), • Percentage of patients with an increase in plasma goserelin at Visit 5 (Day 42) to a value above LLOQ (i.e., presence of goserelin in plasma), • Percentage of patients with plasma testosterone below castrate level (0.5 ng/ml) at Visit 4 (Day 28), • Percentage of patients with plasma testosterone below castrate level (0.5 ng/ml) at Visit 6 (Day 56), • Testosterone levels at baseline (Day 0), at Visit 4 (Day 28) and at Visit 6 (Day 56), • Goserelin levels at Visit 3 (Day 14) and at Visit 5 (Day 42)
Secondary Safety Endpoints: • Clinical examination (i.e. digital rectal examination) of the prostate • Assessment of safety and tolerability: - Adverse Events - Vital signs (blood pressure, heart rate), body weight and temperature - Safety laboratory assessments - Assessment of local tolerability of the implant.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary Efficacy Endpoints: Timepoints of evaluation are included in the above definitions (see E.5.2)
Secondary Safety Endpoints: Clinical Examination of the prostate: day 56 Adverse Events and vital signs: throughout the treatment phase Body weight and temperature: day 0, 28, 56 Safety laboratory: day 0, 28, 56 Local tolerability: day 0, 28, 56
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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 | 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) | 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 | No |
E.8.1.1 | Randomised | No |
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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 2 |
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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |