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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004297-26-IT

Enrollment

750

Registered

2012-10-16

Start date

2012-12-23

Completion date

Unknown

Last updated

2016-04-11

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

Conditions

prostate cancer MedDRA version: 14.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: FECh Product Code: NA Pharmaceutical Form: Solution for injection INN or Proposed INN: CHOLINE CAS Number: 62-49-7 Concentration unit: mCi millicurie(s) Concentration type: equal Concent

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 600

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. to evaluate the diagnostic efficacy –in terms of sensitivity, specificity and accuracy- of PET-TC with [18F]Fluoroethyilcholine ([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 in: a. patients with known prostate cancer, in whom 18F]FECh PET-TC is performed to evaluate loco-regional or distant disease extension (staging); 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.;Secondary Objective: Secondary endpoint of the research program is to assess if a PSA doubling time < 3 months can predict the presence of disease.;Primary end point(s): 1. to evaluate the diagnostic efficacy –in terms of sensitivity, specificity and accuracy- of PET-TC with [18F]Fluoroethyilcholine ([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 in: a. patients with known prostate cancer, in whom 18F]FECh PET-TC is performed to evaluate loco-regional or distant disease extension (staging); 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.;Timepoint(s) of evaluation of this end point: time 0	—

Measure

Time frame

Main Objective: 1. to evaluate the diagnostic efficacy –in terms of sensitivity, specificity and accuracy- of PET-TC with [18F]Fluoroethyilcholine ([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 in: a. patients with known prostate cancer, in whom 18F]FECh PET-TC is performed to evaluate loco-regional or distant disease extension (staging); 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.;Secondary Objective: Secondary endpoint of the research program is to assess if a PSA doubling time < 3 months can predict the presence of disease.;Primary end point(s): 1. to evaluate the diagnostic efficacy –in terms of sensitivity, specificity and accuracy- of PET-TC with [18F]Fluoroethyilcholine ([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 in: a. patients with known prostate cancer, in whom 18F]FECh PET-TC is performed to evaluate loco-regional or distant disease extension (staging); 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.;Timepoint(s) of evaluation of this end point: time 0

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoint of the research program is to assess if a PSA doubling time < 3 months can predict the presence of disease.;Timepoint(s) of evaluation of this end point: time 0	—

Countries

Italy

Contacts

Public ContactIst. Medicina Nucleare

Policlinico Gemelli

A.GIORDANO@RM.UNICATT.IT06 30154978

Outcome results

None listed

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