Clinical trial · Observational
Diagnostic Performance of [18F]PSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biochemical Persistence of Prostate Cancer | — | UNRESOLVED | — |
| Biochemical Recurrence of Malignant Neoplasm of Prostate | — | UNRESOLVED | — |
| Prostate Cancer After a Radical Treatment | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- 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
- description
- Assessment of detection rate of molecular imaging in accordance with composite reference method or histopathological validation, if available
- measure
- Clinical Impact
- timeFrame
- From the timepoint of recruitment on for a time frame of 6 months for each individual
- description
- The assesment of the anticipated rate of therapy change based on the PSMA-PET imaging for the patients with BCR
Secondary outcomes (1)
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDPanagiotidis 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. PMID 37779440
- BACKGROUNDGiesel 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. PMID 29419475
- BACKGROUNDCardinale 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. PMID 27789722