F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence
Primary Purpose
Prostate Cancer, Prostate Cancer Recurrent
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
F-18-PSMA-1007
F-18-Fluorocholine
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Centre Jean Perrin Clermont-Ferrand
- Centre Léon Bérard LUMEN
- Hôpitaux de Brabois (Vandoeuvre-les-Nancy)
- Hôpital Européen Georges-Pompidou
- Hôpital Tenon
- Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
F-18-PSMA-1007
F-18-Fluorocholine
Arm Description
Patients will receive F-18-PSMA-1007 PET/CT first, followed by F-18-Fluorocholine PET/CT.
Patients will receive F-18-Fluorocholine PET/CT first, followed by F-18-PSMA-1007 PET/CT.
Outcomes
Primary Outcome Measures
To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine
Secondary Outcome Measures
Full Information
NCT ID
NCT04102553
First Posted
September 24, 2019
Last Updated
June 28, 2021
Sponsor
ABX advanced biochemical compounds GmbH
1. Study Identification
Unique Protocol Identification Number
NCT04102553
Brief Title
F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence
Official Title
Phase III Study of F-18-PSMA-1007 vs F-18-Fluorocholine PET to Compare the Detection Rate of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
March 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ABX advanced biochemical compounds GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Cancer Recurrent
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F-18-PSMA-1007
Arm Type
Experimental
Arm Description
Patients will receive F-18-PSMA-1007 PET/CT first, followed by F-18-Fluorocholine PET/CT.
Arm Title
F-18-Fluorocholine
Arm Type
Active Comparator
Arm Description
Patients will receive F-18-Fluorocholine PET/CT first, followed by F-18-PSMA-1007 PET/CT.
Intervention Type
Drug
Intervention Name(s)
F-18-PSMA-1007
Intervention Description
Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.
Intervention Type
Drug
Intervention Name(s)
F-18-Fluorocholine
Intervention Description
Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.
Primary Outcome Measure Information:
Title
To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine
Time Frame
Within 6 months after PET/CT
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Centre Jean Perrin Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
Centre Léon Bérard LUMEN
City
Lyon
Country
France
Facility Name
Hôpitaux de Brabois (Vandoeuvre-les-Nancy)
City
Nancy
Country
France
Facility Name
Hôpital Européen Georges-Pompidou
City
Paris
Country
France
Facility Name
Hôpital Tenon
City
Paris
Country
France
Facility Name
Hospices Civils de Lyon
City
Pierre-Bénite
Country
France
12. IPD Sharing Statement
Learn more about this trial
F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence
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