prostate cancer patients MedDRA version: 14.1 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 18F Fluoro Methil Choline
Pharmaceutical Form: Solution for infusion
Current Sponsor code: 18F-FluoroMetilColina
Concentration unit: MBq/ml megabecquerel(s)/millilitre
Concentration type
Sponsors
AZIENDA USL DI FORLI'
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - previous prostate cancer radically treated - PSA>1 ng/ml with an increase of at least 20% in the last 3-6 months - =18 years - written informed consent 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - PSA<1 ng/ml - psichiatric disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: sensitivity of Pet Ct;Secondary Objective: statistical correlation between PET positive and PSA serum level;Primary end point(s): sensitivity of Pet Tac;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): statistical correlation between PET positive and PSA serum level;Timepoint(s) of evaluation of this end point: 1 years | — |
Countries
Italy
Contacts
Public ContactProgramma Ricerca e Innovazione
AUSL di Forli'
Outcome results
None listed