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Phase III prospective clinical trial: 18F-FCH/PET evaluation in early diagnosis of disease recurrence in prostate cancer - FCH_PET

Phase III prospective clinical trial: 18F-FCH/PET evaluation in early diagnosis of disease recurrence in prostate cancer - FCH_PET

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011189-27-IT
Enrollment
Unknown
Registered
2009-03-13
Start date
2009-05-01
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Clinical suspicion of disease relapse in prostate cancer MedDRA version: 9.1 Level: HLT Classification code 10036966 Term: Prostatic neoplasms and hypertrophy

Interventions

Product Name: 18F-fluorocholine chloride Product Code: 18FFCH Pharmaceutical Form: Solution for injection INN or Proposed INN: 18F-Fluorocholine chloride Concentration unit: MBq/ml megabecquerel(s)/mi

Sponsors

ISTITUTI FISIOTERAPICI OSPITALIERI
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Previous Treatment for prostate cancer Biochemical failure Age > 40 years Informed consent 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: Age < 40 years Life expectancy < 1 year

Design outcomes

Primary

MeasureTime frame
Main Objective: 18F-FCH/PET evaluation in early diagnosis of disease recurrence (both local or distant) in prostate cancer;Secondary Objective: Safety evaluation;Primary end point(s): Sensitivity and specificity—

Countries

Italy

Outcome results

None listed

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