E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Detection of abnormal amino acid transport using Positron Emission Tomography (PET) in malignancy |
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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 differentiate the uptake and retention of GE-148 (18F) Injection between malignant prostate tumours, non malignant prostate pathology and normal prostate tissue, in subjects with prostate cancer. |
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E.2.2 | Secondary objectives of the trial |
(1) To assess the relationship between the uptake and retention of GE-148 (18F) Injection in malignant prostate tumours and their Gleason Score.
(2) To assess the relationship between the uptake and retention of GE-148 (18F) Injection with quantitative assessments of AATs and Ki-67 expression in malignant prostate tumours, non malignant prostate pathology, and normal prostate tissue.
(3) To assess the relationship between the uptake and retention of GE-148 (18F) Injection with quantitative assessments of AATs and Ki-67 expression in surgically removed pelvic lymph nodes showing uptake and retention of GE-148 (18F) Injection, where available.
(4) To assess the ability of GE-148 (18F) Injection to detect the number of discrete malignant prostate tumours confirmed by histopathology.
(5) To assess the safety of a single chemical dose of GE-148 (18F) Injection in subjects with prostate cancer. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(1) The subject is a male and is ≥18 years old.
(2) The subject is scheduled to undergo radical prostatectomy with or without pelvic lymphadenectomy within 6 weeks of imaging with GE-148 (18F) Injection.
(3) The subject has biopsy-proven prostate cancer with a minimum of 2 (if <12 biopsy cores are obtained) or 3 (if ≥12 biopsy cores are obtained) positive-for-cancer biopsy cores from one side of the prostate, or at least 20% of the total biopsy area from biopsies taken from one side of the prostate is positive for cancer, or has biopsy-proven prostate cancer and a palpable (by digital rectal examination) nodular tumour, or has biopsy proven prostate cancer and a tumour detected by an ultrasound examination. The biopsy should be performed within 6 months of the study examination.
(4) Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
(5) The subject is able and willing to comply with study procedures, and signed, dated and timed informed consent is obtained before any study-related procedure is performed.
(6) The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings during the screening exam (up to 21 days before administration of study drug).
(7) The subject’s ECG and clinical laboratory tests at screening are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant. |
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E.4 | Principal exclusion criteria |
(1) The subject has received chemotherapy, hormonal therapy or radiation therapy for prostate cancer.
(2) A biopsy has been obtained from the prostate within the 6 weeks before enrolment.
(3) The subject has been previously included in this study.
(4) The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 week after administration of GE-148 (18F) Injection. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Uptake and retention of GE-148 (18F) Injection in malignant prostate tumours, non malignant prostate pathology and normal prostate tissue, calculated as SUVs (SUVmax early, SUVmax late, SUVR [ratio to SUVmean of reference tissue]). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
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 | 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
| 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | 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 | 1 |
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 | 1 |
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 |