Status:
COMPLETED
F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence
Lead Sponsor:
ABX advanced biochemical compounds GmbH
Conditions:
Prostate Cancer
Prostate Cancer Recurrent
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive tr...
Eligibility Criteria
Inclusion
- male with original diagnosis of prostate carcinoma with prior definitive therapy
- suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after prostatectomy)
- life expectancy of 6 months or more as judged by the investigator
- willing and able to undergo all study procedures
- informed consent in writing (dated and signed)
Exclusion
- age: less than18 years
- contraindications for F-18-Fluorocholine
- contraindications for any of the ingredients of F-18-PSMA-1007
- close affiliation with the investigational site; e.g. first-degree relative of the investigator
- at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
- having been previously enrolled in this clinical trial
- mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
- being clinically unstable or requiring emergency treatment
- being considered a vulnerable person
Key Trial Info
Start Date :
March 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04102553
Start Date
March 6 2019
End Date
March 19 2021
Last Update
June 29 2021
Active Locations (6)
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1
Centre Jean Perrin Clermont-Ferrand
Clermont-Ferrand, France
2
Centre Léon Bérard LUMEN
Lyon, France
3
Hôpitaux de Brabois (Vandoeuvre-les-Nancy)
Nancy, France
4
Hôpital Européen Georges-Pompidou
Paris, France