Phase III clinical study of PET-TC with [18f]Fluoroethyilcholine ([18f]Fech) in prostate cancer: assessment of the additional role with respec to conventional imaging techniques

• Conditions: prostate cancer; MedDRA version: 14.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2012-004297-26-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-16
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 750

Inclusion Criteria

- adult male patients with a) known untreated prostate cancer (biopsy); b) biochemical recurrence of prostate cancer after prostatectomy (PSA> 1 ng/ml or PSA doubling time < 3 months); - availability to participate to the study (informed consent); - patients suitable for the diagnostic procedure (PET-TC with 18F-FECh);
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

- patients with recent diagnosis of prostate cancer who started hormone therapy; - patients not suitable for the study protocol;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified