Role of Pet with Choline in prostate cancer patients
- Conditions
- prostate cancer patientsMedDRA version: 14.1Level: PTClassification code 10036911Term: Prostate cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004951-38-IT
- Lead Sponsor
- AZIENDA USL DI FORLI'
- 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
- 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
- PSA<1 ng/ml - psichiatric disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): statistical correlation between PET positive and PSA serum level;Timepoint(s) of evaluation of this end point: 1 years