Impact of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer

NCT ID: NCT06820333

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2030-01-31

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.

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.

Conditions

Prostate Cancer (Adenocarcinoma)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• > 18 years
• Planned [18F]PSMA-1007 PET/CT examination in patients with a first diagnosis of prostate cancer
• Informed consent

Exclusion Criteria

• Examinations with limited assessability due to technical errors, such as imaging artifacts.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Emil Novruzov

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederik Lars Giesel, Prof. Dr., Medical Doctor

Role: STUDY_CHAIR

Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf

Locations

Heinrich Heine University, Medical Faculty, University Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Emil Novruzov, Medical Doctor

Role: CONTACT

Emil.Novruzov@med.uni-duesseldorf.de

(+49)211 8118540

Eduards Mamlins, Medical Doctor

Role: CONTACT

eduards.mamlins@med.uni-duesseldorf.de

(+49)211 8108069

Facility Contacts

Frederik Lars Giesel, Univ.-Prof. Dr. med.

Role: primary

frederik.giesel@med.uni-duesseldorf.de

+492118118540 ext. (+49)81 18540

Eduards Mamlins, Medical Doctor

Role: backup

eduards.mamlins@med.uni-duesseldorf.de

(+49)211 8108069

Other Identifiers

2024-3103

Identifier Type: -

Identifier Source: org_study_id