Evaluation of [18F]Fluorocholine PET/CT imaging for staging and restaging of prostate cancer - 18F-FCH

Conditions: PATIENTS AFFECTED BY PROSTATIC CANCER
MedDRA version: 9.1Level: PTClassification code 10036222

Registration Number: EUCTR2009-016686-28-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI PARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

?Following radical prostatectomy, two consecutive PSA values of 0.2 μg/l and above
?Age > 30 years
?After initial radiation therapy, three consecutive increasing PSA values above the previous PSA nadir measured at 3-month intervals
?Patients with persistently elevated serum levels of prostate-specific antigen (PSA) and negative prostate needle biopsy results
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

?Absence of inclusion criteria
?Age < 30 years
?PSA level < 0.2 ?g/l in prostate cancer patients after radical prostatectomy or radiotherapy
?PSA level < 4 ng/ml in patients with uncertain diagnosis and negative prostate needle biopsy
?Extensive calcification in the examination area
?Current urinary infection
?Not signed Informed Consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Aim of the study is to evaluate the role of [18F]Fluorocholine PET/CT: <br>-in the assessment of suspected recurrence of prostate cancer after treatment in patients with elevated PSA-level <br>-in the detection of prostate cancer in patients with elevated PSA-level and negative prostate needle;Secondary Objective: 1. To evaluate accuracy of [18F]FCH PET/CT in localizing prostate cancer or detecting recurrence of the disease in comparison with radiological imaging techniques (CT, MRI); <br>2. To develop standardized protocols for PET/CT imaging, tracer uptake evaluation and equipe training.;Primary end point(s): Aim of the study is to evaluate the role of [18F]Fluorocholine PET/CT: <br>-in the assessment of suspected recurrence of prostate cancer after treatment in patients with elevated PSA-level <br>-in the detection of prostate cancer in patients with elevated PSA-level and negative prostate needle

Secondary Outcome Measures