E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intermediate or high risk 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 | 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 |
The primary trial objective is to assess the effects of docetaxel as compared to surveillance on the occurrence of prostate specific antigen (PSA) progression |
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E.2.2 | Secondary objectives of the trial |
The secondary trial objective is to assess the effects of docetaxel compared to surveillance on PSA doubling time, quality of life, metastasis-free survival, and overall survival. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria
• > 18 and ≤75 years of age. • Radical radiotherapy for prostate cancer. • WHO/ECOG performance status 0 – 1. • Histological proven adenocarcinoma of the prostate within 9 months prior to randomisation. • One of the following: - T2 with Gleason score (4+3) and PSA >10 ng/ml. - T2 with Gleason score of 8-10, and any PSA. - Any T3 tumour. • Prior neoadjuvant hormone therapy is mandatory for all patients • Adequate haematological-, liver- and kidney function: (Haemoglobin greater than or equal to 110 g/l, neutrophils greater than or equal to 1.5 x 10 to the power of 9/ l, platelets greater than or equal to 150 x 10 to the power of 9/ l, ASAT and ALAT less than or equal to 1.5 x UNL, ALP < 1.5 x UNL, bil less than or equal to UNL, creatinine less than or equal to 1.5 x UNL) • Written informed consent. - ALAT and ASAT less than or equal to 2.5 x UNL, Alk. Phos < 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 equal to 1.5 x UNL (ie NCI grade < 1)
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E.4 | Principal exclusion criteria |
• M+ (Positive bone scan indicating spread of tumour or visceral metastases). • Node+ • 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 radiotherapy to the pelvic region for other cancer. • Previous chemotherapy within 5 years. • Systemic corticosteroids within 6 months prior to randomisation. • Unstable cardiovascular disease, including myocardial infarction, within 6 months prior to randomisation. • Active untreated infectious disease, including tuberculosis, MRSA. • Active gastric ulcer. • Known hypersensitivity to Polysorbate 80 (an excipient of docetaxel) • Other serious illness or medical condition. • Symptomatic peripheral neuropathy ≥ CTCAE grade 2. • Patients who by altered physical or psychological state are not able to co-operate or participate in the trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to treatment failure
1) the progression of the disease will be defined as:
Progression in PSA when there are two increasing values registered at least 2 weeks apart. Time to progression is calculated from the date of randomisation until the day progression is first registered as a PSA value >4 ng/ml.
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 | 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 | Yes |
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 |
Treatment arm is Docetaxel (Taxotere®) i.v. treatment. Control arm is No Docetaxel treatment. |
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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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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 |