Diagnostic imaging in prostate cancer (as in tumours with accelerated menbrane turn-over)by F-18 Fluoro-metil-choline PET/CT
- Conditions
- patients with prostate cancer istologically provenTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 14.1Level: SOCClassification code 10038359Term: Renal and urinary disordersSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 14.1Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations
- Registration Number
- EUCTR2008-003337-24-IT
- Lead Sponsor
- CENTRO DI RIFERIMENTO ONCOLOGICO DI BASILICATA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
locally advanced (previously treated as well) and metastatic prostate cancer istologically proven
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
oAge <30 yrs o >90 yrs
o Gleason >8.
oPSA <0.2ng/ml
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: PET/CT using F18 FMC for staging, restaging and therapy assessment of prostate cancer;Secondary Objective: to correlate findings with PSA levels;Primary end point(s): Diagnostic accuracy of F-18 FMC;Timepoint(s) of evaluation of this end point: 48 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): metastatic assessment and therapy efficacy;Timepoint(s) of evaluation of this end point: 48 months