E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intermediate or high-risk prostate cancer treated with radical radiotherapy |
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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 |
Primary objective: time to PSA progression |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: PSA doubling time, Quality of Life (QoL), Safety, Metastases free survival, Overall survival. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. > 18 and ≤75 years of age 2. Radical radiotherapy for prostate cancer 3. WHO/ECOG performance status 0 – 1 4. Histologically proven adenocarcinoma of the prostate within 9 months prior to randomisation. 5. One of the following: T2 with Gleason 7 (4+3) and PSA >10 ng/ml T2 with Gleason 8-10, any PSA any T3 tumours. 6. Prior neoadjuvant hormone therapy is mandatory for all patients 7. Adequate haematological-, liver- and kidney function (less than 1.5 x UNL for creatinine, less than 1.5 X UNL for liver laboratory values except bil < UNL). 8.Written informed consent. |
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E.4 | Principal exclusion criteria |
1. M+ 2. N+ 3. 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. 4. Previous radiotherapy to pelvic region. 5. Previous chemotherapy within five years. 6. Systemic corticosteroids within 6 months prior to randomisation. 7. Unstable cardiovascular disease within 6 months prior to randomisation. 8. Active untreated infectious disease. 9. Active gastric ulcer. 10. Known hypersensitivity to Polysorbate 80. 11. Other serious illness or medical condition. 12. Symptomatic peripheral neuropathy ≥ CTCAE grade 2. 13. 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) |
Compare time to PSA progression in intermediate or high-risk prostate cancer patients between chemotherapy+ hormonal treatment versus hormonal treatment alone |
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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 | Yes |
E.6.12 | Pharmacoeconomic | Yes |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | 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.8.5 | 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 | 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 |
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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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Patient will receive 6 cycles of chemotherapy unless unacceptable tocixity or patient refusal |
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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 | 9 |