F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence
NCT ID: NCT04102553
Last Updated: 2021-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2019-03-06
2021-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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F-18-PSMA-1007
Patients will receive F-18-PSMA-1007 PET/CT first, followed by F-18-Fluorocholine PET/CT.
F-18-PSMA-1007
Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.
F-18-Fluorocholine
Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.
F-18-Fluorocholine
Patients will receive F-18-Fluorocholine PET/CT first, followed by F-18-PSMA-1007 PET/CT.
F-18-PSMA-1007
Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.
F-18-Fluorocholine
Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.
Interventions
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F-18-PSMA-1007
Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.
F-18-Fluorocholine
Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
MALE
No
Sponsors
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ABX advanced biochemical compounds GmbH
INDUSTRY
Responsible Party
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Locations
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Centre Jean Perrin Clermont-Ferrand
Clermont-Ferrand, , France
Centre Léon Bérard LUMEN
Lyon, , France
Hôpitaux de Brabois (Vandoeuvre-les-Nancy)
Nancy, , France
Hôpital Européen Georges-Pompidou
Paris, , France
Hôpital Tenon
Paris, , France
Hospices Civils de Lyon
Pierre-Bénite, , France
Countries
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References
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Olivier P, Giraudet AL, Skanjeti A, Merlin C, Weinmann P, Rudolph I, Hoepping A, Gauthe M. Phase III Study of 18F-PSMA-1007 Versus 18F-Fluorocholine PET/CT for Localization of Prostate Cancer Biochemical Recurrence: A Prospective, Randomized, Crossover Multicenter Study. J Nucl Med. 2023 Apr;64(4):579-585. doi: 10.2967/jnumed.122.264743. Epub 2022 Nov 23.
Other Identifiers
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ABX-CT-301
Identifier Type: -
Identifier Source: org_study_id
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