E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Men, 18-70 years old, who have had radical prostatectomy due to prostate cancer and with a high grade pT3 or margin positive pT2 tumour may be candidates for the study. |
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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 |
PSA progression after adjuvant Taxotere treatment compared to surveillance after radical prostatectomy . |
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E.2.2 | Secondary objectives of the trial |
PSA doubling time Overall survival Metastasis free survival Quality of life |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
*Men > 18 and ≤70 years of age. *WHO/ECOG performance status 0 – 1. *Histologically proven adenocarcinoma of the prostate. *Either of the following: - pT2 with Gleason score 4+3 or 8-10 and positive margins in the radical prostatectomy specimen or - any pT3 tumour with Gleason score 4+3 or higher. *If pre-operative PSA ≥10.0 ng/ml, lymph node dissection should be performed. *Post-operative PSA ≤ 0.5 ng/ml. *Adequate haematological-, liver- and kidney function. *Negative bone scan prior to study start. *Written informed consent. |
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E.4 | Principal exclusion criteria |
*M+ (Positive bone scan indicating spread of tumour). *N+ (Known positive lymph nodes at histological examination). *Patients with a history of previous malignant disease. Exceptions should be made for basal cell carcinoma (BCC) and squamous cell carcinoma of the skin. Exceptions should also be made for curatively treated malignant disease, which has been disease free for the past five years. *Previous hormonal manipulation (e.g. LHRH analogues and/or antiandrogens) affecting prostate cancer cells. *Previous radiotherapy to pelvic region. *Previous chemotherapy. *Systemic corticosteroids within 6 months prior to randomisation. *Unstable cardiovascular disease within 6 months prior to randomisation. *Active untreated infectious disease. *Active gastric ulcer. *Known hypersensitivity to Polysorbate 80. *Other serious illness or medical condition. *Symptomatic peripheral neuropathy ≥ CTCAE grade 2. *Patients who by altered physical or psychological state not are able to co-operate or participate in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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.8.5 | 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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End of trial is when 50% of the patients in the surveillance arm have reached PSA progression or at the latest 5 years after the last patient has been included. |
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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 | 8 |
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 | 8 |