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Evaluation of 18F-choline PET/CT accuracy in a selected population of patients with malignant tumor of prostate, in relation to PSA serum level and its kinetics, in any examined patient.

Evaluation of diagnosic accuracy of 18F-choline PET/CT in examination of patients qith prostate cancer, in relation to PSA value and its derivatives.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-002470-23-IT
Enrollment
Unknown
Registered
2012-03-07
Start date
2011-06-09
Completion date
Unknown
Last updated
2014-06-10

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

Conditions

Patients with prostate cancer histologically proved MedDRA version: 14.1 Level: SOC Classification code 10038604 Term: Reproductive system and breast disorders System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 14.1 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: SOC Classification code 10038359 Term: Renal and urinary disorders System Organ Class: 10038359 - Renal and u

Interventions

Trade Name: 18F-choline Pharmaceutical Form: Radiopharmaceutical precursor INN or Proposed INN: NA CAS Number: NA Current Sponsor code: NA Other descriptive name: NA Concentration unit: MBq megabecque

Sponsors

ISTITUTO NEUROLOGICO MEDITERRANEO NEUROMED
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Staging and restaging of patients with prostate cancer histologically diagnosed 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: PSA serum level

Design outcomes

Primary

MeasureTime frame
Main Objective: Define di diagnostica accuracy of 18F-choline PET/CT in evaluation of prostate cancer patients;Secondary Objective: evaluate this performance in relation to PSA serum level and its kinetics in any patient;Primary end point(s): Diagnostic Accuracy of 18F-choline PET/CT in relation with PSA serum level and PSA kinetics.;Timepoint(s) of evaluation of this end point: 24 months—

Secondary

MeasureTime frame
Secondary end point(s): definition of further localizations of pathology, other than prostate (lymph nodes, bone, other).;Timepoint(s) of evaluation of this end point: 24months—

Countries

Italy

Contacts

Public ContactMedicina Nucleare

IRCCS INM Neuromed

direzionescientifica@neuromed.it0865929522

Outcome results

None listed

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