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
1 other identifier
observational
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2024
CompletedFirst Posted
Study publicly available on registry
October 24, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
January 17, 2025
January 1, 2025
2.1 years
October 23, 2024
January 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Prognostic value of [18F]PSMA-1007 for the patients with BCR
From the timepoint of recruitment on for a time frame of 24 months for each individual
Eligibility Criteria
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.
You may qualify if:
- Informed Consent
- Conduct of \[18F\]PSMA-1007 PET Imaging in the context of regular clinical care
You may not qualify if:
- Technical Flaws in the acquisition protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Related Publications (3)
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.
PMID: 37779440BACKGROUNDGiesel 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: 29419475BACKGROUNDCardinale 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: 27789722BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Frederik Lars Giesel, Prof. Dr., Medical Doctor
Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Board Certified Nuclear medicine Physician
Study Record Dates
First Submitted
October 23, 2024
First Posted
October 24, 2024
Study Start
November 1, 2024
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
November 30, 2028
Last Updated
January 17, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- From the completion of the first study year by December 2025 up to the study end.
- Access Criteria
- The investigators plan to operate according to official requests via E-mail or website of clinicaltrials.gov.
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.