Diagnostic value of 18F-choline PET/CT for the detection of systemic prostate cancer disease. - 2008-CaP-FCH

Phase 1

• Conditions: de novo patients with histologically confirmed prostate cancer; MedDRA version: 12.0Level: LLTClassification code 10060862Term: Prostate cancer

• Registration Number: EUCTR2009-014839-21-FR
• Lead Sponsor: CIS bio international, member of IBA group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-07
• Study Completion: 2013-06-30
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

1. Male
2. Age > or = 18 years
3. De novo patient with histologically confirmed prostate cancer and high risk disease according to D’AMICO criteria: stages > or = T2c and/or PSA > or = 20 ng/ml and/or Gleason score > or = 8, or Gleason score = 7 with either predominance of grade 4 or percentage of positive biopsy > 50%
4. Patient who has already been imaged by contrast-enhanced thoraco-abdominal CT and bone scintigraphy
5. Patient who is able to undergo all study procedures and who has signed a written informed consent form to participate in the study

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

1. Surgery within the last 4 weeks prior to the administration of [18F]-FCH
2. History of other malignant tumor
3. Previous radiation therapy
4. Prostate biopsy within 4 weeks before [18F]-FCH PET/CT
5. Concomitant medications containing choline
6. Severe allergic reaction to any of the ingredients of the choline formulation
7. Participation in another clinical study within one month prior to inclusion
8. Uncooperative, in the investigator's opinion
9. Linguistic or psychological inability to sign the informed consent form and/or take part in the study
10. Having already participated in this clinical trial

Study & Design

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