E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic Hormone Refractory Prostate Cancer. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
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 |
The study is designed to evaluate the effect of biweekly docetaxel monotherapy compared to the docetaxel monotherapy given every third week in the treatment of metastatic hormone refractory prostate cancer (HRPC). The primary objective of the study is to compare time to treatment failure in the two arms of the study: defined as: 1a) progression in PSA (defined by AUA guidelines) 1b) progression of evaluable or measurable metastases 2) unacceptable toxicity 3) patient's refusal to continue treatment 4) death
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are: • Quality of life • Response rates • Safety • Overall survival |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria: (1) Histologically/ cytologically proven adenocarcinoma of prostate. (2) Metastatic disease (confirmed by imaging or clinical examination) (3) Hormone refractory prostate cancer defined as rising PSA values in 2 sequential measurements (4) Testosterone levels must be within the institutions castration levels. (5) PSA > 10 μg/l (6) No previous cytostatic treatment except estramustine phosphate which should be stopped ≥3 weeks before starting trial medication. (7) Anti-androgen treatment must be stopped ≥3 weeks before starting trial medication. (8) WHO performance status < or = 2 (9) Age > 18 years (10) Laboratory requirements : (a) Haematology : - neutrophils > or = 1.5 x 10 to the power of 9 /l - hemoglobin > or = 110 g/l , HB > 100 g/l in Sweden - platelets > or = 100 x 10 to the power of 9 /l (b) Hepatic function : - total bilirubin < or = 1 x UNL - ALAT and ASAT < or = 2.5 x UNL, Alk. Phos < or = 6 x UNL. In the presence of extensive bone disease, Alk. Phos is > 6 x UNL, the patient should be eligible in the study. (c) Renal function : -Creatinine < or = 1.5 x UNL (ie NCI grade < or = 1)
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E.4 | Principal exclusion criteria |
Exclusion Criteria: (1) Less than 4 weeks since the completion of surgery. (2) Prior radiotherapy > 25% of bone marrow (3) Less than 3 weeks since estramustine phosphate treatment (4) Prior therapy with radioisotopes (5) Other malignant disease/ malignancy (except basalioma) within the past 5 years. (6) Serious liver disease (7) Other serious illness or medical condition: (a) Serious cardiac disease; ischemic or tromboembolic cardiac disease, pulmonary emboli, cardiac infarction within 12 months (b) Active infection (c) Active peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids. (d) Auto-immune disease (lupus, scleroderma, rheumatoid polyarthritis)
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is: Time to treatment failure in both arms of the study Time to Treatment failure:
1) the progression of the disease will be defined as: 1a) progression in PSA (defined by AUA guidelines) 1b) progression of evaluable or measurable metastases
2) unacceptable toxicity
3) patient's refusal to continue treatment
4) death
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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 | Yes |
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 | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
same study drug Taxotere but with different dosage and treatment schedule |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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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last visit of 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 | 3 |
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 | 3 |