E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
prostate cancer (and metastases) |
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E.1.1.1 | Medical condition in easily understood language |
prostate cancer (and metastases) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
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 |
The main objective is the demonstration of the safety, radiation dosimetry and efficacy of [18F]-PSMA-11 PET/CT.
Phase 1: The primary objective is to establish the safe administration and biodistribution of intravenous [18F]-PSMA-11; occurrence of adverse events according to common toxicity criteria.
Phase 2: - Evaluation of effective targeting of prostate cancer and eventual metastases with [18F]PSMA-11: visual and/or semi-quantitative (SUV) analysis - Determination of the optimal scan protocol: time of scanning, duration of scan, optimal radioactivity dose (2.0 ± 0.2 vs 4.0 ± 0.4 MBq/kg body weight) Extension: evaluation of the added value of furosemide (to improve diuresis), as part of the standard scanprotocol |
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E.2.2 | Secondary objectives of the trial |
Phase 1: Secondary endpoints are the organ dosimetry and establishment of critical organs (mGy/MBq), the total body effective dose (mSV/MBq), description of the kinetics of the radioligand and the occurrence of metabolites in plasma and urine.
Phase 2: - Evaluation of the inter-observer difference for interpretation of [18F]PSMA-11 scans - Evaluation of the diagnostic specificity of [18F]PSMA-11 - Evaluation of the impact of the [18F]PSMA-11 scan on the choice of therapy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging. |
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E.4 | Principal exclusion criteria |
- Age < 40 or > 70 years in phase-1; age <18 years in phase-2 trial - Physically or mentally unfit to perform the sequential procedures - Refusal of patient to be informed about accidental findings on scans - Patients with heart failure if ejection fraction < 45% (phase 2 trial) - History of anaphylactic shock after administration of Visipaque CT contrast (phase 2 trial) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Phase 1: The primary objective is to establish the safe administration and biodistribution of intravenous [18F]-PSMA-11; occurrence of adverse events according to common toxicity criteria.
Phase 2: - Evaluation of effective targeting of prostate cancer and eventual metastases with [18F]PSMA-11: visual and/or semi-quantitative (SUV) analysis - Determination of the optimal scan protocol: time of scanning, duration of scan, optimal radioactivity dose (2.0 ± 0.2 vs 4.0 ± 0.4 MBq/kg body weight) Extension: evaluation of the added value of furosemide (to improve diuresis), as part of the standard scanprotocol |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
0-24 hours post-administration |
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E.5.2 | Secondary end point(s) |
Phase 1: Secondary endpoints are the organ dosimetry and establishment of critical organs (mGy/MBq), the total body effective dose (mSV/MBq), description of the kinetics of the radioligand and the occurrence of metabolites in plasma and urine.
Phase 2: - Evaluation of the inter-observer difference for interpretation of [18F]PSMA-11 scans - Evaluation of the diagnostic specificity of [18F]PSMA-11 - Evaluation of the impact of the [18F]PSMA-11 scan on the choice of therapy. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
0-60 days post [18F]PSMA-11 injection |
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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 | Yes |
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) | Yes |
E.7.1.1 | First administration to humans | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 |
extension of phase II is not longer randomised nor blinded |
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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 |
comparison of two different doses of the same product |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.5 | 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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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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LVLS + 60 days for data collection and blood sampling (blood sampling not applicable for the extension of phase II) |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | 0 |