Trials / Completed
CompletedNCT04644822
Safety and Efficacy of [18F]PSMA-1007 Injection in Suspected Persistent or Recurrent Prostate Cancer.
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.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Centre for Probe Development and Commercialization · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | [18F] PSMA-1007 Injection | a novel \[18F\] PSMA radiotracer that is highly selective for PSMA. |
Timeline
- Start date
- 2020-12-21
- Primary completion
- 2024-01-08
- Completion
- 2024-01-08
- First posted
- 2020-11-25
- Last updated
- 2024-02-07
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT04644822. Inclusion in this directory is not an endorsement.