E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
1. improve the differential diagnosis between tumor recurrence and outcome fibrocicatriziali or inflammatory processes; 2nd identify more successfully and as early as the presence of local tumor recurrence or secondary locations allowing highlight metabolic changes associated with the presence of disease before they have altered the size and morphology of the structures under consideration |
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E.2.2 | Secondary objectives of the trial |
To value the extent of disease, locally and remotely, through the execution of a single investigation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with histological diagnosis of early prostate cancer, surgically treated with radical intent, which, after a month after, we have not observed the reset of PSA (> 0.2 ng / ml, but not> 2 ng / ml ). 2nd Patients with histological diagnosis of early prostate cancer, surgically treated with radical intent with zero PSA after 1 month, which is a documented biochemical recurrence with PSA values> 0.2 and <2 ng / ml, allowing a subsequent radiotherapy in rescue. 3rd Patients with histological diagnosis of prostate cancer early, to be treated with radiotherapy with radical intent, to define the "Biological Target Volume" 4th Patients with histological diagnosis of early prostate cancer treated with radiotherapy with radical intent, which, after 18 months, after reaching the nadir, the PSA shows an increase> 2 ng / ml. 5th Patients with histological diagnosis of early prostate cancer, already treated with radical intent with surgery or radiotherapy and / or hormonal therapy, with bone scintigraphy and / or abdominal and pelvic CT showing a situation of oligometastatizzazione, in which case the PET-CT with choline defining the actual extent of metastasis, for proper selection of patients by radiation therapy to address in order to prolong and improve the survival with no macroscopic disease. 6th Staging of disease highly aggressive prostate cancer (Gleason> 7). The data emerging in the literature survey PET-CT with 18F-choline appears to have in these patients a higher sensitivity than conventional all`imaging. |
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E.4 | Principal exclusion criteria |
Patients outside indication |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. In the presence of biochemical recurrence: a. % Of local recurrences seen in the PET-CT 18F-choline, compared with CI; b. % Of lesions visible at a distance to PET-CT 18F-choline, compared with CI; 2nd In anticipation of Radiotherapy aims to save local recurrence or in cases of suspected recurrence oligometastatica: a. Definition of local BTV; b. Change in definition of disease at a distance of PET-CT 18F-choline, compared with CI. 3rd In the absence of biochemical relapse in aggressive forms where the trend all`indifferenziazione makes PSA a reliable marker is not in doubt of recovery of the disease: a. % Of lesions visible at PET-CT 18F-choline, compared with CI |
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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 | 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 | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
Metodica tradizionale: TAC |
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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
| |
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 | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |