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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03344822

Acronym

TePSMAG-68

Enrollment

Registered

2017-11-17

Start date

2018-01-02

Completion date

2019-12-31

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

68Ga-PSMA PET

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.

Interventions

DIAGNOSTIC_TEST68Ga-PSMA-11

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

DIAGNOSTIC_TEST18F-Choline PET-CT

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
percentage of modification of management intent	1 month	modification of management intent after 68Ga-PSMA PET-CT and 18F-Choline PET-CT

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026