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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Emil Novruzov, Medical Doctor; Phone Number: (+49)211 8118540; Email: Emil.Novruzov@med.uni-duesseldorf.de
• Study Contact Backup: Name: Eduards Mamlins, Medical Doctor; Phone Number: (+49)211 8108069; Email: eduards.mamlins@med.uni-duesseldorf.de

Study Locations

• Germany
  • NRW
    • Düsseldorf, NRW, Germany, 40225
      • Recruiting
      • Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf
      • Contact: Eduards Mamlins, Medical Doctor; Phone Number: (+49)211 8108069; Email: eduards.mamlins@med.uni-duesseldorf.de
      • Contact: Frederik Lars Giesel, Univ.-Prof. Dr. med.; Email: frederik.giesel@med.uni-duesseldorf.de
      • Contact: Emil Novruzov, Medical Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patient cohort will consist of biologically male patients with a histopathologically proven prostate cancer following a curative-intent cancer therapy. These patients will be referred to our center due to suspected recurrence.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA-Stratified Detection rate of [18F]PSMA-1007 in BCR	Assessment of detection rate of molecular imaging in accordance with composite reference method or histopathological validation, if available	From the timepoint of recruitment on for a time frame of 6 months for each individual
Clinical Impact	The assesment of the anticipated rate of therapy change based on the PSMA-PET imaging for the patients with BCR	From the timepoint of recruitment on for a time frame of 6 months for each individual

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic value of [18F]PSMA-1007 for the patients with BCR	Assessment of prognostic value of [18F]PSMA-1007 imaging in terms of recurrence-free Survival and overall survival	From the timepoint of recruitment on for a time frame of 24 months for each individual

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Study Chair: Frederik Lars Giesel, Prof. Dr., Medical Doctor, Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: prostate cancer; biochemical recurrence; 18F-PSMA-1007; [18F]PSMA-1007; biochemical persistence
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Neoplasms; Prostatic Neoplasms; Recurrence
• Other Study ID Numbers: 2024-2995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators plan to provide the IPD including the patient characteristics and study protocol. On a reasonable request, the investigators would also provide patient data with respect to evaluation of primary and secondary outcomes.
• IPD Sharing Time Frame: From the completion of the first study year by December 2025 up to the study end.
• IPD Sharing Access Criteria: The investigators plan to operate according to official requests via E-mail or website of clinicaltrials.gov.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No