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

NCT ID: NCT06657131

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2028-11-30

Brief Summary

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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

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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).

Conditions

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Prostate Cancer After a Radical Treatment Biochemical Recurrence of Malignant Neoplasm of Prostate Biochemical Persistence of Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Emil Novruzov

Board Certified Nuclear medicine Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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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

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

Düsseldorf, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Emil Novruzov, Medical Doctor

Role: CONTACT

(+49)211 8118540

Eduards Mamlins, Medical Doctor

Role: CONTACT

(+49)211 8108069

Facility Contacts

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

Role: primary

Eduards Mamlins, Medical Doctor

Role: backup

(+49)211 8108069

Emil Novruzov, Medical Doctor

Role: backup

References

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Panagiotidis E, Fragkiadaki V, Papathanasiou N, Kypraios C, Liatsikos E, Klampatsas A, Paschali A, Exarhos D, Zarokosta F, Chatzipavlidou V, Apostolopoulos D, Datseris I. Comparison of 18F-PSMA-1007 and 18F-Choline PET/CT in prostate cancer patients with biochemical recurrence: a phase 3, prospective, multicenter, randomized study. Nucl Med Commun. 2023 Dec 1;44(12):1126-1134. doi: 10.1097/MNM.0000000000001770. Epub 2023 Oct 2.

Reference Type BACKGROUND
PMID: 37779440 (View on PubMed)

Giesel FL, Will L, Kesch C, Freitag M, Kremer C, Merkle J, Neels OC, Cardinale J, Hadaschik B, Hohenfellner M, Kopka K, Haberkorn U, Kratochwil C. Biochemical Recurrence of Prostate Cancer: Initial Results with [18F]PSMA-1007 PET/CT. J Nucl Med. 2018 Apr;59(4):632-635. doi: 10.2967/jnumed.117.196329. Epub 2018 Feb 1.

Reference Type BACKGROUND
PMID: 29419475 (View on PubMed)

Cardinale J, Schafer M, Benesova M, Bauder-Wust U, Leotta K, Eder M, Neels OC, Haberkorn U, Giesel FL, Kopka K. Preclinical Evaluation of 18F-PSMA-1007, a New Prostate-Specific Membrane Antigen Ligand for Prostate Cancer Imaging. J Nucl Med. 2017 Mar;58(3):425-431. doi: 10.2967/jnumed.116.181768. Epub 2016 Oct 27.

Reference Type BACKGROUND
PMID: 27789722 (View on PubMed)

Other Identifiers

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2024-2995

Identifier Type: -

Identifier Source: org_study_id

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