Diagnostic Performance and Clinical Impact of [18F]PSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer: a Real-World Evidence from a Monocentric, Prospective Observational Phase-4-Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- PSA-Stratified Detection rate of [18F]PSMA-1007 in BCR
Study Overview
Brief Summary
Following numerous retrospective studies and Phase-3-Studies with promising results, [18F]PSMA-1007 has been approved by european authorities. Therefore, it is a growing deployment of this diagnostic method anticipated. This study aims to investigate the diagnostic performance and clinical impact in a real-world-evidence in the context of regular clinical care. The evidence generated by this approach is supposed to assist in optimizing the management of prostate cancer patients.
Detailed Description
The advent of PSMA diagnostics and therapy has constituted a paradigm shift in the management of prostate cancer, supplanting other clinical and radiological diagnostic techniques. Consequently, [18F]PSMA-1007 (Radelumin®) has been approved in several EU countries, most recently in Germany in 2024, for use in primary staging of high-risk prostate cancer and re-staging in the context of biochemical recurrence (BCR). This may be regarded as a landmark in the management of prostate cancer, with the potential to markedly enhance the uptake of PSMA-PET diagnostics in the coming years.
The intention is to generate evidence-based data in everyday clinical practice with this so-called Real-World-Evidence (RWE) study. The planned study will facilitate a more detailed analysis of the diagnostic accuracy of Radelumin® in everyday clinical practice. This will involve dedicated examinations of certain subgroups and the prospective generation of a complete, high-quality database for future use of artificial intelligence (AI).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed Consent
- •Conduct of [18F]PSMA-1007 PET Imaging in the context of regular clinical care
Exclusion Criteria
- •Technical Flaws in the acquisition protocol
Outcomes
Primary Outcomes
PSA-Stratified Detection rate of [18F]PSMA-1007 in BCR
Time Frame: From the timepoint of recruitment on for a time frame of 6 months for each individual
Assessment of detection rate of molecular imaging in accordance with composite reference method or histopathological validation, if available
Clinical Impact
Time Frame: From the timepoint of recruitment on for a time frame of 6 months for each individual
The assesment of the anticipated rate of therapy change based on the PSMA-PET imaging for the patients with BCR
Secondary Outcomes
- Prognostic value of [18F]PSMA-1007 for the patients with BCR(From the timepoint of recruitment on for a time frame of 24 months for each individual)
Investigators
Dr. med. Emil Novruzov
Board Certified Nuclear medicine Physician
Heinrich-Heine University, Duesseldorf