Biochemical Persistence of Prostate Cancer, Biochemical Recurrence of Malignant Neoplasm of Prostate, Prostate Cancer After a Radical Treatment
Conditions
Keywords
prostate cancer, biochemical recurrence, 18F-PSMA-1007, [18F]PSMA-1007, biochemical persistence
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).
Interventions
None listed
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA-Stratified Detection rate of [18F]PSMA-1007 in BCR | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Assessment of prognostic value of \[18F\]PSMA-1007 imaging in terms of recurrence-free Survival and overall survival |
Countries
Germany
Contacts
Primary ContactEmil Novruzov, Medical Doctor
Backup ContactEduards Mamlins, Medical Doctor
Outcome results
None listed