Actively Recruiting
The Clinical Impact and Prognostic Value of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer: Real-world Evidence From a Monocentric, Prospective Observational Study
Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-02-11
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of 18F-PSMA-1007 (Radelumin®) imaging for the primary staging of high-risk prostate cancer. This diagnostic method has changed how prostate cancer is managed by replacing other clinical and radiological techniques. The study aims to collect real-world evidence on the diagnostic accuracy and prognostic value of Radelumin® during routine clinical care, addressing limitations seen in earlier studies by including a larger and more diverse patient population with long-term follow-up. The study involves performing 18F-PSMA-1007 PET/CT scans on patients with newly diagnosed prostate cancer who are planned for this imaging procedure. Since this is an observational study, no experimental treatments are assigned. Instead, the study collects detailed data from these imaging examinations and follows patients over time to evaluate how well the imaging detects cancer spread and relates to clinical and pathological features. Participants will undergo 18F-PSMA-1007 PET/CT scans as part of their standard care, with data collected prospectively. They will be followed up at 1 year, 2 years, and 5 years to assess clinical outcomes and correlate PET scan results with disease features. The main measurement is the diagnostic accuracy of the imaging method, with interim analyses annually and a final analysis after 5 years. This approach helps understand the real-world use and value of this imaging technique in prostate cancer management.
CONDITIONS
Brief Title
Impact of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male
- 18 years of age or older
- Planned to have an [18F]PSMA-1007 PET/CT scan for a first diagnosis of prostate cancer
- Able to provide informed consent
You will not qualify if you...
- Imaging examinations with technical problems that limit assessment, such as artifacts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of scan
Participants undergo an [18F]PSMA-1007 PET/CT scan for the primary staging of prostate cancer as part of routine clinical care.
1 visit (in-person)
Duration - Up to 5 years
Participants are observed over time to assess diagnostic accuracy and prognostic value, with follow-up assessments at 1 year, 2 years, and 5 years.
Follow-up visits at 1 year, 2 years, and 5 years
Trial Site Locations
Total: 1 location
1
Heinrich Heine University, Medical Faculty, University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
Research Team
E
Emil Novruzov, Medical Doctor
E
Eduards Mamlins, Medical Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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