E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
prostatic carcinoma higly suspected or its staging or restaging |
karcinom prostaty - vysoké podezření, staging nebo restaging |
|
E.1.1.1 | Medical condition in easily understood language |
prostatic carcinoma higly suspected or its staging or restaging |
karcinom prostaty - vysoké podezření, staging nebo restaging |
|
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 |
relation of the accumulation level with biological behavior of the tumorosu tissue, degree of the tumorou spread within an organism and serum levels of prostatic specific antigene |
vztah úrovně akumulace radiofarmaka s biologickou povahou nádoru, dále stupněm rozšíření nádorového onemocnění v organismu a sérovými hladinami prostatického specifického antigenu |
|
E.2.2 | Secondary objectives of the trial |
to validate imaging protocol |
validovat zobrazovací protokol |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
prostatic carcinoma higly suspected or its staging or restaging in male older than 18, WHO performance status 1 or 2 |
karcinom prostaty - vysoké podezření, staging nebo restaging u mužů starších 18ti let, WHO performance status 1 nebo2 |
|
E.4 | Principal exclusion criteria |
WHO performance status 3 or 4, renal mpairment |
WHO performance status 3 nebo 4, renální selhání |
|
E.5 End points |
E.5.1 | Primary end point(s) |
relation of the accumulation level with biological behavior of the tumorosu tissue, degree of the tumorou spread within an organism and serum levels of prostatic specific antigene |
vztah úrovně akumulace radiofarmaka s biologickou povahou nádoru, dále stupněm rozšíření nádorového onemocnění v organismu a sérovými hladinami prostatického specifického antigenu |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
early evaluation after 15 - 20 examinations, than intermediate after 50 , 100 and 150 |
časná evaluace po 15 - 20 vyšetřeních, pak intermediální po 50 , 100 and 150 |
|
E.5.2 | Secondary end point(s) |
validation of the imaging protocol |
validace zobrazovacího protokolu |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
early evaluation after 15 - 20 examinations, than intermediate after 50 , 100 and 150 |
časná evaluace po 15 - 20 vyšetřeních, pak intermediální po 50 , 100 and 150 |
|
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 | No |
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 | 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 | No |
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 | No |
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
| 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 | 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |