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PET-CT DIAGNOSIS OF CARCINOMA PROSTATICO WITH ALTERNATIVE TO FLUORODESOSSIGLUCOSIO Radio: 18F-COLINA - ND

PET-CT DIAGNOSIS OF CARCINOMA PROSTATICO WITH ALTERNATIVE TO FLUORODESOSSIGLUCOSIO Radio: 18F-COLINA - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-004236-20-IT
Enrollment
Unknown
Registered
2009-03-24
Start date
2008-06-24
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

Sponsors

AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients outside indication

Design outcomes

Primary

MeasureTime frame
Main Objective: 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;Secondary Objective: To value the extent of disease, locally and remotely, through the execution of a single investigation.;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

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026