E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Enrolled patients will be those who have a diagnosis of prostate cancer and for whom medical castration by means of Luteinising Hormone Releasing Hormone analogue (LHRHa) injection is indicated. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
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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 evaluate the efficacy of Decapeptyl SR when given by SC injection in patients with prostate cancer. This will be determined by evaluating the proportion of patients who achieve Serum Total Testosterone Castration Level (STTCL) 4 months after the first injection. |
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E.2.2 | Secondary objectives of the trial |
1.To evaluate the efficacy of an initial treatment with Decapeptyl SR 3 mg when given by SC injection. This will be determined by evaluating the proportion of pts who achieve STTCL 1 month after the first injection. 2. To evaluate the efficacy of a repeat treatment with Decapeptyl SR 11.25 mg SC injection. This will be determined by evaluating the proportion of pts who achieve STTCL 1 month after the second injection. 3. To assess changes in plasma triptorelin levels after administration of Decapeptyl SR by SC route at assessment time-points in comparison to Baseline. 4. To assess changes in the levels of Serum Total Testosterone (STT) and Prostate Specific Antigen (PSA), after administration of Decapeptyl SR via the SC route at all assessment time-points in comparison to Baseline. Safety & Tolerability Objectives: 1. To assess the safety of Decapeptyl SR when administered by SC injection. 2. To assess the tolerability of Decapeptyl SR when administered by SC injection.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria Patients must fulfil all of the following criteria in order to be included in the study: 1. The patient has given written (personally signed and dated) informed consent before starting any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal medical care. 2. The patient is male and is 18 years of age or older. 3. The patient has a histologically or cytologically confirmed diagnosis of prostate cancer and meets the following criteria: Stage T3 or T4, N (any), M (any) with a PSA >5ng/ml or Biochemical relapse following radical prostatectomy or radical radiotherapy for prostate cancer 4. Medical castration by means of LHRHa therapy is indicated for the patient. 5. The patient has a life expectancy of at least 12 months. 6. The patient is able and willing to comply with the requirements of the protocol.
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E.4 | Principal exclusion criteria |
1. The patient has undergone bilateral orchidectomy. 2. The patient is either scheduled to receive, receiving, or is anticipated to require any chemotherapy for prostate cancer, or any other cancer, during the period of his participation in the study. 3. The patient is either scheduled to receive, or anticipated to require any surgical intervention for their prostate cancer during the period of his study participation. 4. The patient has any condition that in the opinion of the Investigator may preclude the administration of subcutaneous Decapeptyl SR injections. 5. The patient has received treatment with any LHRHa, within 1 year prior to study entry. 6. The patient has a history of hypersensitivity to Decapeptyl SR or cyproterone acetate (CPA), or to any of the excipients of Decapeptyl SR or CPA. 7. The patient has any contraindication to treatment with anti-androgens, including, but not limited to clinically significant abnormalities in liver function. 8. The patient has been treated with oestrogens or steroid androgens within the 12 months prior to screening, or is receiving treatment with non-steroid anti-androgens at the time of the Screening visit. 9. The patient, in the opinion of the Investigator is at risk of serious complications in the event of tumour flare (e.g. vertebral metastases threatening spinal cord compression, significant obstructive uropathy) on initiation of Decapeptyl SR treatment despite concomitant treatment with anti-androgens. 10. The patient has any other condition that, in the opinion of the Investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. 11. The patient is likely to require treatment during the study with drugs that are not permitted by the study protocol. 12. The patient has been treated with any investigational drug or therapy, within the last 30 days prior to study entry. 13. The patient has a history of, or known current, problems with alcohol abuse. 14. The patient has any mental condition rendering him unable to understand the nature, scope and possible consequences of the study 15. The patient has previously been enrolled in the study
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients with Serum Total Testosterone (STT) ≤50 ng/dL 4 months after their first injection of Decapeptyl SR |
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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 | No |
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) | 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) | 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 | 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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The end of the trial is determined by last patient last visit. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |