E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with prostate cancer histologically proved |
Pazienti con diagnosi istologica di carcinoma prostatico |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with malignant tumor of prostate |
Pazienti con tumore malogno della prostata |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10038604 |
E.1.2 | Term | Reproductive system and breast disorders |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022891 |
E.1.2 | Term | Investigations |
E.1.2 | System Organ Class | 10022891 - Investigations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10038359 |
E.1.2 | Term | Renal and urinary disorders |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
|
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 |
Define di diagnostica accuracy of 18F-choline PET/CT in evaluation of prostate cancer patients |
Definire la performance diagnostica della PET/TC con 18F-colina nella valutazione dei pazienti con carcinoma prostatico |
|
E.2.2 | Secondary objectives of the trial |
evaluate this performance in relation to PSA serum level and its kinetics in any patient |
correlare tale performance ai valori di PSA e suoi derivati documentati in ogni singolo paziente |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Staging and restaging of patients with prostate cancer histologically diagnosed |
Carcinoma prostatico istologicamente diagnosticato in stadiazione e ristadiazione |
|
E.4 | Principal exclusion criteria |
PSA serum level |
PSA sierico |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Diagnostic Accuracy of 18F-choline PET/CT in relation with PSA serum level and PSA kinetics. |
Accuratezza diagnostica della PET/TC con 18F colina in relazione ai valori di PSA e derivati. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
definition of further localizations of pathology, other than prostate (lymph nodes, bone, other). |
definizione delle eventuali ulteriori localizzazioni di patologia eccetto la prostata (linfonodi, ossa, altro) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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) | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 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
|
End of the trial with the last exam(n300°) or 24 months after the beginning |
Completamento dello studio all'esame n.300 (ovvero dopo 24 mesi dall'inizio) |
|
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 | 24 |
E.8.9.1 | In the Member State concerned days | 0 |