Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-31 @ 7:24 AM
Study NCT ID:
NCT06820333
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2025-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer
Sponsor:
Heinrich-Heine University, Duesseldorf
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The introduction of PSMA diagnostics and therapy has fundamentally changed the treatment management of prostate cancer and has significantly replaced other clinical and radiological diagnostic methods. As a result, 18F-PSMA-1007 (Radelumin®) was approved in Germany and several EU countries, most recently in Germany in 01/2024, for use in primary staging of high-risk prostate cancer and re-staging in the context of biochemical recurrence (BCR). This could be seen as a milestone in the management of prostate cancer and will significantly promote the widespread use of PSMA-PET diagnostics in the coming years.
The investigators now intend to prospectively generate evidence-based data in everyday clinical practice with this so-called Real-World-Evidence (RWE) study. The planned study will enable us to analyze the diagnostic accuracy of Radelumin® in more detail under everyday conditions, whereby dedicated examinations of certain subgroups and the prospective generation of a complete, high-quality database for the future use of artificial intelligence (AI) will be made possible.
The investigators now intend to prospectively generate evidence-based data in everyday clinical practice with this so-called Real-World-Evidence (RWE) study. The planned study will enable us to analyze the diagnostic accuracy of Radelumin® in more detail under everyday conditions, whereby dedicated examinations of certain subgroups and the prospective generation of a complete, high-quality database for the future use of artificial intelligence (AI) will be made possible.
Detailed Description:
Depending on the study design and definition of the patient population, the detection rate of pelvic lymph nodes in particular using PSMA imaging is reported to be \>80%. The results of the studies thus demonstrate a superior diagnostic accuracy compared to previous methods as well as a significant influence of PSMA imaging on the clinical course. Radelumin® was approved on the basis of these promising results from numerous retrospective studies and the prospective, randomized approval study.
Nevertheless, it should be noted that the results derived from such data generally deviate from the data in everyday clinical practice for various reasons. Furthermore, the retrospectively planned studies show multiple general weaknesses, whereby the prospective randomized approval studies also show a priori weaknesses. These result from a very limited observation phase and the lack of long-term data, despite good planning with a high power, a small number of patients and the targeted homogeneity of the patient population. In the context of a real-world evidence study, which focuses on routine clinical care, the above-mentioned disadvantages are compensated for by long-term observation, a considerably larger patient population and a realistic patient mix.
Nevertheless, it should be noted that the results derived from such data generally deviate from the data in everyday clinical practice for various reasons. Furthermore, the retrospectively planned studies show multiple general weaknesses, whereby the prospective randomized approval studies also show a priori weaknesses. These result from a very limited observation phase and the lack of long-term data, despite good planning with a high power, a small number of patients and the targeted homogeneity of the patient population. In the context of a real-world evidence study, which focuses on routine clinical care, the above-mentioned disadvantages are compensated for by long-term observation, a considerably larger patient population and a realistic patient mix.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: