E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
metastatic prostate cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
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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 |
To compare [18F]choline to [11C]choline in their ability to detect metastatic prostate cancer. |
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E.2.2 | Secondary objectives of the trial |
1. To compare the best early phase (immediate) scanning of the two agents against the late phase (one hour delayed) [18F]choline scanning in their ability to detect metastatic prostate cancer.
2. To assess the safety of [11C]choline and [18F]choline in patients with prostate cancer. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologically proven prostate cancer
2. At least 4 new metastatic bone lesions, as identified by conventional imaging with bone scintigraphy
3. Either: a) Treatment naive for prostate cancer OR b) Castration refractory prostate cancer [castrate will be defined as a testosterone level of <50 ng/dL (<2 nM)] with progressive disease (PD). PD will be defined by fulfilment of at least one of the following criteria: • PSA progression defined as a rising PSA according to Prostate Cancer Working Group 2 (PCWG2) criteria • Soft tissue disease progression defined by RECIST 1.1 (Eisenhauer E.A., et al., 2009) • Bone disease progression defined by PCWG2 with two or more lesions on bone scan
These patients will either have previously known bone metastases on bone scintigraphy and are now progressing on LHRHa with or without maximum androgen blockade, or, will not previously have had known bone metastases
4. Life expectancy of at least 12 weeks
5. World Health Organisation (WHO) performance status of 0, 1, or 2
6. Haematological and biochemical indices within the ranges shown below performed within 24 hours prior to administration on Day 1 (Day -1 to Day 1).
Laboratory TestValue required Haemoglobin (Hb) ≥9.0 g/dL Platelet count ≥100 x 10(9)/L Serum bilirubin ≤1.5 x upper limit of normal (ULN) ALT and AST ≤2.5 x ULN (unless raised due to tumour when ≤5 x ULN is permissible)
7. 18 years or over
8. Written (signed and dated) informed consent and able to comply with study assessments and follow-up
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E.4 | Principal exclusion criteria |
1. For treatment naive patients any prior radiotherapy, hormone therapy, chemotherapy, endocrine therapy, or immunotherapy, for treatment of prostate cancer
For castration refractory patients any prior radiotherapy, chemotherapy, or immunotherapy for treatment of prostate cancer
2. Patients with partners of child-bearing potential (unless they agree to take measures not to father children by using two forms of medically approved contraception during the trial)
3. Patients with the following conditions which would prevent compliance with the scanning protocol: - Diabetes - High levels of pain / discomfort - Urinary incontinence
4. Major thoracic and/or abdominal surgery from which the patient has not yet recovered.
5. History of recent significant cardiac arrhythmia
6. Concurrent congestive heart failure or prior history of class III/IV cardiac disease (NYHA)
7. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial
8. Participation or planned participation in any other interventional clinical trial, whilst taking part in this trial. Participation in an observational trial would be acceptable.
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E.5 End points |
E.5.1 | Primary end point(s) |
Identification of a true 5% difference in lesion detection using the [18F]choline to [11C]choline |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 trial’ is defined as the last visit of the last patient participating in the trial. This will either be completion of the last patient’s Off-Study visit if no IMP-related AEs have been seen, or the last visit following any IMP-related AE monthly follow-up visits. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |