patients with prostate cancer istologically proven MedDRA version: 14.1 Level: SOC Classification code 10038359 Term: Renal and urinary disorders System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: F18 FMC
Product Code: NA
Pharmaceutical Form: Radiopharmaceutical precursor
Other descriptive name: FMC F18
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentrati
Sponsors
CENTRO DI RIFERIMENTO ONCOLOGICO DI BASILICATA
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria: o Age 90 yrs o Gleason >8. o PSA <0.2ng/ml
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): metastatic assessment and therapy efficacy;Timepoint(s) of evaluation of this end point: 48 months | — |
Countries
Italy
Contacts
Public ContactMedicina Nucleare
IRCCS - CENTRO DI RIFERIMENTO ONCOLOGICO DI BASILICATA
Outcome results
None listed