E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neoadjuvant docetaxel prior to radical prostatectomy for high risk localised prostate cancer. Evaluation of biological and functional imaging surrogates of therapy efficacy |
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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 |
To pilot and test the feasibility of chemotherapy with docetaxel followed by radical prostatectomy for high risk prostate cancer incorporating laboratory and imaging measurements of therapeutic effectiveness, and so investigate whether these measures may be used to define who may benefit from this management strategy. |
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E.2.2 | Secondary objectives of the trial |
To establish the basis for a prospective trial of neo-adjuvant docetaxel prior to radical prostatectomy in high risk prostate cancer.
To compare the value of functional MRI (Dynamic contrast-enhanced MRI [DCE-MRI], diffusion weighed imaging (DWI) or magnetic resonance spectroscopy [MRS]) in detecting prostate cancer tumour volume, activity and any related changes in response to neoadjuvant chemotherapy.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• High risk prostate cancer: PSA >20 ng/mL or a Gleason score of 8 to 10 or clinical stage T2c and greater (American Urological Association criteria) • Nx/M0 • Eastern Cooperative Oncology Group performance status 0 or 1 • Adequate haematological, renal and hepatic function • Suitable for and selection of radical prostatectomy as therapy • Informed consent
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E.4 | Principal exclusion criteria |
• Age <18 years old • Previous local radical intervention for prostate cancer • Previous hormonal or other systemic therapy for prostate cancer • Previous non skin malignancy • Having received investigational drug in another clinical study of anticancer therapy within 4 weeks of starting study treatment • Contraindication to magnetic resonance imaging (MRI) or prostate needle biopsy • Exclusion criteria related to docetaxel: • Inadequate organ and bone marrow function as evidenced by: • Haemoglobin <10.0g/dL • Absolute neutrophil count < 1.5 x 10.9/L • Platelet count <100 x 10.9/L • AST and /or ALT >1.5 x ULN • Alkaline phosphatase levels > 2.5 x ULN • Total bilirubin > 1.0 x ULN
• Contraindications to the use of corticosteroid treatment
• Symptomatic peripheral neuropathy grade >2 (National Cancer Institute Common Terminology Criteria V.3) • Any medical or psychiatric condition which would influence the ability of patients to provide consent • Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial • Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease • requiring antiretroviral therapy. • Any of the following within 6 months prior to randomization: myocardial infarction, • Severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack
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E.5 End points |
E.5.1 | Primary end point(s) |
Evidence of a biological and/or pathological and/or imaging change induced by docetaxel therapy on the in vivo prostate tumours prior to surgery. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | No |
E.8.1.2 | Open | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Prospective cohort window trial |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
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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The end of the trial is defined as the last follow-up review of the last patient. Beyond this point, patients will continue to be followed as per local guidelines, and information regarding disease outcome will be collected. |
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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 | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |