Safety and Efficacy of [18F]PSMA-1007 Injection in Suspected Persistent or Recurrent Prostate Cancer.

Official Title

A Phase 3, Non-randomized, Open Label, Multi-centre Clinical Trial to Investigate the Safety and Efficacy of [18F]PSMA-1007 Injection in Men With Suspected Persistent or Recurrent Prostate Cancer.

Summary:

This is a prospective, Phase 3 non-randomized, open label, multi-centre clinical trial to assess the safety and efficacy of [18F]PSMA-1007 Injection (investigational product or IP) in evaluating men with suspected persistent or recurrent disease (i.e., with biochemical failure), but with negative or equivocal conventional re-staging imaging (bone scan [BS] and computed tomography [CT] of abdomen and pelvis).

Trial Description

Primary Outcome:

• Primary Endpoint:

• Safety: Occurrence of AEs, SAEs, and changes from baseline in vital signs
• Percentage of patients identified with recurrent disease using [18F]PSMA-1007
• Frequency with which [18F]PSMA-1007 PET/CT results lead to a change in recommended management

View this trial on ClinicalTrials.gov