Clinical trial NCT06657131: Diagnostic Performance of [18F]PSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer After a Radical Treatment
Biochemical Recurrence of Malignant Neoplasm of Prostate
Biochemical Persistence of Prostate Cancer
Keywords: prostate cancer
biochemical recurrence
18F-PSMA-1007
[18F]PSMA-1007
biochemical persistence
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: PSA-Stratified Detection rate of [18F]PSMA-1007 in BCR
timeFrame: From the timepoint of recruitment on for a time frame of 6 months for each individual
measure: Clinical Impact
timeFrame: From the timepoint of recruitment on for a time frame of 6 months for each individual
Secondary outcomes:
measure: Prognostic value of [18F]PSMA-1007 for the patients with BCR
timeFrame: From the timepoint of recruitment on for a time frame of 24 months for each individual
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf
state: NRW
Study officials:
affiliation: Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf
name: Frederik Lars Giesel, Prof. Dr., Medical Doctor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.