Diagnostic Performance of [18F]PSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer

Recruiting

• Conditions: Prostate Cancer After a Radical Treatment; Biochemical Recurrence of Malignant Neoplasm of Prostate; Biochemical Persistence of Prostate Cancer

• Registration Number: NCT06657131
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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 Timeline

• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-24
• Study Start: 2024-11-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Primary Completion: 2026-11-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf; 🇩🇪 Düsseldorf, NRW, Germany