Evaluation of 18F-choline PET/CT accuracy in a selected population of patients with malignant tumor of prostate, in relation to PSA serum level and its kinetics, in any examined patient.
- Conditions
- Patients with prostate cancer histologically provedMedDRA version: 14.1Level: SOCClassification code 10038604Term: Reproductive system and breast disordersSystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 14.1Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.1Level: SOCClassification code 10038359Term: Renal and urinary disordersSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002470-23-IT
- Lead Sponsor
- ISTITUTO NEUROLOGICO MEDITERRANEO NEUROMED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Staging and restaging of patients with prostate cancer histologically diagnosed
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Exclusion Criteria
PSA serum level
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Define di diagnostica accuracy of 18F-choline PET/CT in evaluation of prostate cancer patients;Secondary Objective: evaluate this performance in relation to PSA serum level and its kinetics in any patient;Primary end point(s): Diagnostic Accuracy of 18F-choline PET/CT in relation with PSA serum level and PSA kinetics.;Timepoint(s) of evaluation of this end point: 24 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): definition of further localizations of pathology, other than prostate (lymph nodes, bone, other).;Timepoint(s) of evaluation of this end point: 24months