PHASE II CLINICAL STUDY OF THE DIAGNOSTIC EFFICACY OF [18F]FLUOROETHYILCHOLINE ([18F]FECh) IN PATIENTS WITH PROSTATE CANCER - ND

Conditions: PROSTATE CANCER
MedDRA version: 9.1Level: HLTClassification code 10036908Term: Prostatic neoplasms malignant

Registration Number: EUCTR2008-008301-22-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

-adult male patients with a) known prostate cancer (biopsy) and eligible for surgical treatment; b) biochemical recurrence of prostate cancer after prostatectomy (PSA> 0.2 ng/ml)
-availability to participate to the study (informed consent);
-patients suitable for the diagnostic procedure (PET-TC with 18F-FECh);
-patients with life expectancy > 2 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-patients not suitable for the study protocol;
-patients with life expectancy < 2 months

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.to evaluate the diagnostic efficacy ?in terms of sensitivity, specificity and accuracy- of PET-TC with [18F]Fluoroethyilcholine ([18F]FECh) in:<br>a.patients with known prostate cancer, in whom 18F]FECh PET-TC is performed to evaluate loco-regional or distant disease extension (staging);<br>b.patients previously treated for prostate cancer who present at follow-up elevated PSA levels, in whom 18F]FECh PET-TC is performed to localize the neoplastic lesions;<br>2.to evaluate the additional role of PET-TC with [18F]FECh with respect to the other diagnostic imaging techniques that are routinely used such as ultrasonography with trans-rectal probe, computed tomography (CT), magnetic resonance (MR) and bone scintigraphy.;Secondary Objective: is to perform dosimetric evaluation of [18F]FECh in a group of patients with prostate cancer.;Primary end point(s): nd

Secondary Outcome Measures