Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients

Phase 2

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: 68Ga-PSMA-11; Diagnostic Test: 18F-Choline PET-CT

• Registration Number: NCT03344822
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-15
• Last Update Submitted: 2017-11-15
• Study First Posted: 2017-11-17
• Last Update Posted: 2017-11-17
• Study Start: 2018-01-02
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 33

Inclusion Criteria

• high risk prostate cancer patients with initial tests : CT, bone scintigraphy and 18F-Choline

Exclusion Criteria

• contraindication of 68Ga-PSMA PET-CT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-PSMA PET-CT	68Ga-PSMA-11	-
68Ga-PSMA PET-CT	18F-Choline PET-CT	-

Primary Outcome Measures

Name	Time	Method
percentage of modification of management intent	1 month	modification of management intent after 68Ga-PSMA PET-CT and 18F-Choline PET-CT

Trial Locations

Locations (1)

Central hospital Nancy; 🇫🇷 Nancy, France