Back to resultsPlace of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients (TePSMAG-68)
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
68Ga-PSMA-11
18F-Choline PET-CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring 68Ga-PSMA PET
Eligibility Criteria
Inclusion Criteria:
- high risk prostate cancer patients with initial tests : CT, bone scintigraphy and 18F-Choline
Exclusion Criteria:
- contraindication of 68Ga-PSMA PET-CT
Sites / Locations
- Central hospital Nancy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-PSMA PET-CT
Arm Description
Outcomes
Primary Outcome Measures
percentage of modification of management intent
modification of management intent after 68Ga-PSMA PET-CT and 18F-Choline PET-CT
Secondary Outcome Measures
Full Information
NCT ID
NCT03344822
First Posted
November 14, 2017
Last Updated
November 15, 2017
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT03344822
Brief Title
Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients
Acronym
TePSMAG-68
Official Title
Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients in Comparaison of 18F-Choline PET-CT
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2018 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Several studies have shown a great potential of 68Ga-PSMA PET in high risk prostate cancers patients and a high detection rate than 18F-Choline PET.
The primary aim of this study is to evaluate the difference of management intent, after the inital staging of high risk prostate cancer patients, with 68Ga-PSMA-11 PET-CT results in comparison of 18F-Choline PET-CT results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
68Ga-PSMA PET
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Each patient will realize a 18F-Choline PET/CT then a 68Ga-PSMA-11 PET/CT
Masking
None (Open Label)
Masking Description
Even if the study has only one arm, the results of both PET imageries will be blind assessed.
Allocation
N/A
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-PSMA PET-CT
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-PSMA-11
Intervention Description
radioactive tracer for PET-CT (68Ga-PSMA-11)
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-Choline PET-CT
Intervention Description
radioactive tracer for PET-CT (18F-Choline PET-CT)
Primary Outcome Measure Information:
Title
percentage of modification of management intent
Description
modification of management intent after 68Ga-PSMA PET-CT and 18F-Choline PET-CT
Time Frame
1 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
high risk prostate cancer patients with initial tests : CT, bone scintigraphy and 18F-Choline
Exclusion Criteria:
contraindication of 68Ga-PSMA PET-CT
Facility Information:
Facility Name
Central hospital Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine Claudin, Doctor
Email
m.claudin@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Pierre Olivier, Professor
First Name & Middle Initial & Last Name & Degree
Pascal Eschwege, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients
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