Place 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)

Central Hospital, Nancy, France

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Prostate Cancer

Treatments: Diagnostic Test: 68Ga-PSMA-11; Diagnostic Test: 18F-Choline PET-CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03344822

PSS2016/TePSMAG-68-CLAUDIN/VS

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• contraindication of 68Ga-PSMA PET-CT

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

68Ga-PSMA PET-CT

Experimental group

Treatment:

Diagnostic Test: 68Ga-PSMA-11

Diagnostic Test: 18F-Choline PET-CT