F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence

Phase 3 Completed 200 enrolled ABX advanced biochemical compounds GmbH

RandomizedCrossoverOpen-labelDiagnostic

Summary

This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.

Timeline

Start: 2019-03-06
Primary completion: 2020-10-30
Completion: 2021-03-19

Outcome

Met primary endpoint

paper The primary endpoint was met. PMID 36418170 ↗

paper The overall correct detection rates were 0.82 for 18F-PSMA-1007 and 0.65 for 18F-fluorocholine (P < 0.0001) PMID 36418170 ↗

Publications

Olivier P, Giraudet AL, Skanjeti A, Merlin C, Weinmann P, Rudolph I, Hoepping A, Gauthe M. Phase III Study of 18F-PSMA-1007 Versus 18F-Fluorocholine PET/CT for Localization of Prostate Cancer Biochemical Recurrence: A Prospective, Randomized, Crossover Multicenter Study. J Nucl Med. 2023 Apr;64(4):579-585. doi: 10.2967/jnumed.122.264743. Epub 2022 Nov 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	F-18 PSMA 1007	Diagnostic / imaging agent	—	—
Subject	F-18-Fluorocholine	Diagnostic / imaging agent	—	—