| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Prostate cancer without detectable metastases following initial escape from hormone treatment |
|
| 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 |
| The primary objective of the trial is to determine the efficacy and safety of ONY-P vaccines |
|
| E.2.2 | Secondary objectives of the trial |
| The secondary objective of the trial is to calculate the actual hazard ratio in the target population and so determine the sample size required for a definitive Phase III study. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
A patient is eligible for the trial if all of the following inclusion criteria are met:
A patient of any age with documented histologically confirmed prostate cancer and a life expectancy of at least six months.
A patient previously treated with any licensed hormone therapy (except oestrogens) and/or orchidectomy. The patient must continue to receive the same hormone therapy at the same dose throughout the trial.
Patients who have received the following licensed treatments and/or orchidectomy must have documented evidence of a nadir plasma testosterone level of less than 50ng/dL on hormonal treatment: LHRH agonists, combined androgen blockade. Patients who have been treated with androgen monotherapy are not required to have documented evidence of a nadir plasma testosterone level of less than 50ng/dL on hormaonal treatment, however, testosterone levels must be recorded.
A patient with a documented hormone break through prostate cancer indicated by a rise in serum PSA on at least 2 successive occasions separated by at least 4 weeks while continuing to receive hormone therapy prior to Week-4.
A patient with a serum PSA level of at least 2ng/ml at Week –4 that is higher than at least one of the two previous serum PSA levels all separated by at least 4 weeks between the tests.
A patient with no radiological evidence of bone or soft tissue metastases in the four week period prior to randomisation.
A patient with a haemoglobin level of 10g/dL or more at Week -2
A patient with a white cell count of 2500 per cu cm or more at Week –2
A patient with no two liver enzymes more than 5 times the ULN at Week-2
A patient must have the ability to read and understand the patient information sheet and to give written informed consent.
A patient must be able and willing to attend the Hospital for all trial treatments and assessments for the duration of the trial.
A patient must agree to be followed up irrespective of whether they left the trial early or they are discontinued from the trial or they completed the trial.
|
|
| E.4 | Principal exclusion criteria |
A patient will not be eligible for the trial if any of the following criteria are met:
A patient who has no documented histological confirmation of prostate cancer
A patient with clinical or radiological evidence of metastatic prostate disease.
A patient previously treated with the following licensed treatments and/or orchidectomy with no documented evidence of a nadir plasma testosterone level of less than 50ng/dL on hormonal treatment: LHRH agonists, combined androgen blockade. Patients receiving oestrogens for treatment of their prostate cancer are not eligible for the study.
A patient who has a PSA level < 2ng/ml at Week -2.
A patient who has had a previous malignancy or has an active malignancy other than prostrate cancer with the exception of basal cell carcinoma of the skin.
A patient who has a life expectancy of less than 6 months.
A patient who has a known immunodeficiency.
A patient who is receiving any therapy with a known immunosuppressive activity.
A patient who has taken oral/inhaled/ parental corticosteroids up to 1 month prior to screening or is proposing to take or likely to take during the trial.
A patient who has taken oestrogens or ketoconazole up to 1 month prior to screening or is likely to take during the trial.
A patient who has been treated with cytotoxic therapy up to 3 months prior to screening into the trial.
A patient who has been treated with any investigational medicinal product up to 3 months prior to screening or during the trial.
A patient who has a known hypersensitivity to the one or more components of the trial medications.
A patient who has had previous exposure to a prostate cancer vaccine.
A patient who is unable or unwilling to attend all visits and assessments.
A patient who is unable to understand the patient information sheet or is unable to give written informed consent.
A patient with an active tuberculosis infection
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Progression Free Survival (PFS) at 12 months is the primary efficacy variable. The corresponding primary efficacy parameter will be the duration of PFS, calculated as the time from randomisation to progression or to the time of death (for patients who die whithout progressing). Progression is defined as the appearance of soft tissue or bone metastases as determined by radiological procedures and assessed as set out in the separate radiology protocol. The appearance of bone lesions must be confirmed by a second bone scan taken three months after the lesion is first recorded. If the lesion is confirmed at the second scan, the date of progression will be backdated to the date of the first scan when progression was recorded. Such patients will remain in the trial and continue treatment with study medication until the result of a confirmatory scan is known, unless they are withdrawn due to clinical progression. |
|
| 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 | Yes |
| 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 | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| 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 | Yes |
| 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 | 2 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 8 |
| 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 |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| 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
|
| Last visit of last subject undergoing trial. |
|
| 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 | 7 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 7 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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