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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.
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).
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
This study investigates the diagnosic potential of PSMA-PET imaging in patients with a histopathologically proven prostate cancer. Therefore, all participants will be only biologically male patients.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emil Novruzov, Medical Doctor | Contact | (+49)211 8118540 | Emil.Novruzov@med.uni-duesseldorf.de | |
| Eduards Mamlins, Medical Doctor | Contact | (+49)211 8108069 | eduards.mamlins@med.uni-duesseldorf.de |
| Name | Affiliation | Role |
|---|---|---|
| Frederik Lars Giesel, Prof. Dr., Medical Doctor | Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf | Recruiting | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37779440 | Background | 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. | |
| 29419475 |
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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.
From the completion of the first study year by December 2025 up to the study end.
The investigators plan to operate according to official requests via E-mail or website of clinicaltrials.gov.
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|
| Background |
| 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. |
| 27789722 | Background | 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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