Diagnostic Performance of 18F-PSMA-1007 PET/CT in Suspected Prostate Cancer Patient
- Registration Number
- NCT05422105
- Lead Sponsor
- Primo Biotechnology Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 230
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Suspected Prostate Cancer 18F-PSMA-1007 -
- Primary Outcome Measures
Name Time Method Diagnostic Performance 7-14 days after PET/CT Sensitivity, Specificity, NPV, PPV
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Tungs'Taichung Metro Harbor Hospital
🇨🇳Taichung, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan