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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-016686-28-IT
Enrollment
Unknown
Registered
2010-04-07
Start date
2010-04-14
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PATIENTS AFFECTED BY PROSTATIC CANCER MedDRA version: 9.1 Level: PT Classification code 10036222

Interventions

Product Name: fluoro-choline Pharmaceutical Form: Solution for injection Concentration unit: MBq/ml megabecquerel(s)/millilitre Concentration type: equal Concentration number: 222-

Sponsors

AZIENDA OSPEDALIERA DI PARMA
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Aim of the study is to evaluate the role of [18F]Fluorocholine PET/CT: -in the assessment of suspected recurrence of prostate cancer after treatment in patients with elevated PSA-level -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); 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: -in the assessment of suspected recurrence of prostate cancer after treatment in patients with elevated PSA-level -in the detection of prostate cancer in patients with elevated PSA-level and negative prostate needle—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026