Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657131
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
Diagnostic Performance of 18FPSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diagnostic Performance and Clinical Impact of 18FPSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer a Real-World Evidence from a Monocentric Prospective Observational Phase-4-Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
18FPSMA-1007
Brief Summary:
Following numerous retrospective studies and Phase-3-Studies with promising results 18FPSMA-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 18FPSMA-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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None