Multicenter Evaluation of Diagnostic Performance of [18F]FPSMA-1007 PET/CT in Patients With Suspected Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- 18F-PSMA-1007
- Conditions
- Prostate Cancer
- Sponsor
- Primo Biotechnology Co., Ltd
- Enrollment
- 230
- Locations
- 2
- Primary Endpoint
- Diagnostic Performance
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The diagnostic tools for detecting patients with early prostate cancer are limited due to poor diagnostic performance. The positron emission tomography (PET) combination with the diagnostic radiopharmacy is a non-invasive tool to provide the molecular imaging of the whole body and offer more comprehensive physiological information and then can raise the diagnostic performance. Prostate-specific membrane antigen (PSMA)-targeting pharmaceuticals have been regarded as the most promising diagnostic tool to diagnose patients with prostate cancer. Currently, the 18F-PSMA-1007 as PSMA-targeting 18F-radiolabeled pharmaceuticals have developed and successfully used in patients with intermittent- and high-risk prostate cancer or recurrent prostate cancer. The study aims to understand the diagnostic performance of 18F-PSMA-1007 PET/CT in different-stage prostate cancer patients by initiating the first multicenter clinical trial of 18F-PSMA-1007 in Taiwan.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Suspected Prostate Cancer
Intervention: 18F-PSMA-1007
Outcomes
Primary Outcomes
Diagnostic Performance
Time Frame: 7-14 days after PET/CT
Sensitivity, Specificity, NPV, PPV