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

NCT ID: NCT03344822

Last Updated: 2017-11-17

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Keywords

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68Ga-PSMA PET

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each patient will realize a 18F-Choline PET/CT then a 68Ga-PSMA-11 PET/CT
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Even if the study has only one arm, the results of both PET imageries will be blind assessed.

Study Groups

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68Ga-PSMA PET-CT

Group Type EXPERIMENTAL

68Ga-PSMA-11

Intervention Type DIAGNOSTIC_TEST

radioactive tracer for PET-CT (68Ga-PSMA-11)

18F-Choline PET-CT

Intervention Type DIAGNOSTIC_TEST

radioactive tracer for PET-CT (18F-Choline PET-CT)

Interventions

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68Ga-PSMA-11

radioactive tracer for PET-CT (68Ga-PSMA-11)

Intervention Type DIAGNOSTIC_TEST

18F-Choline PET-CT

radioactive tracer for PET-CT (18F-Choline PET-CT)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* contraindication of 68Ga-PSMA PET-CT
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Central hospital Nancy

Nancy, , France

Site Status

Countries

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France

Facility Contacts

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Marine Claudin, Doctor

Role: primary

Other Identifiers

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PSS2016/TePSMAG-68-CLAUDIN/VS

Identifier Type: -

Identifier Source: org_study_id