NCT Number: NCT06657131
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.
Interested in participating?
Request Info18 year and older
Male
Observational
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Location status: Recruiting
Eduards Mamlins, Medical Doctor
CONTACT
(+49)211 8108069
Emil Novruzov, Medical Doctor
CONTACT
Frederik Lars Giesel, Univ.-Prof. Dr. med.
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Eduards Mamlins, Medical Doctor
CONTACT
(+49)211 8108069
Emil Novruzov, Medical Doctor
CONTACT
(+49)211 8118540
Heinrich-Heine University, Duesseldorf
Other
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
Acronym: [18F]PSMA-1007
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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