Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer
NCT ID: NCT06122584
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
380 participants
INTERVENTIONAL
2024-06-13
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[18F]PSMA-1007
Single intravenous administration of \[18F\]PSMA-1007 for Positron Emission Tomography (PET) scan
[18F]PSMA-1007
Diagnostic radiopharmaceutical for PET scan
Interventions
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[18F]PSMA-1007
Diagnostic radiopharmaceutical for PET scan
Eligibility Criteria
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Inclusion Criteria
2. The patient is able to understand the information presented to him concerning the nature, scope, and consequences of the trial as set out in the information provided to the patient AND has provided written informed consent to participate.
3. The patient has newly diagnosed, biopsy-proven, clinically localized prostate adenocarcinoma, and curative prostatectomy with extended pelvic lymph node dissection is his preferred course of treatment.
4. The patient has at least high-risk disease as defined by the NCCN guidelines (version 1.2023). That is, the presence of any one or more of the following:
* Overall ISUP grade group 4 or 5,
* Clinical category T3a or greater,
* Serum PSA level greater than 20 ng/ml.
5. The patient has undergone conventional imaging (CT or MRI, and bone scan if clinically indicated) to detect the presence of pelvic nodal involvement and bone or visceral metastases within 60 days of the planned PET-CT procedure.
Exclusion Criteria
2. The patient has received any therapy - be it radiation, surgical or drug therapy - for his prostate cancer.
3. The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of \[18F\]PSMA-1007.
4. The patient is not able to have PET-CT scans (for example, because of weight, claustrophobia, or inability to lie still for the duration of the scan).
5. The patient is closely affiliated to the investigation site; e.g. is a first-degree relative of the investigator.
6. At the time of screening, the patient is receiving any other investigational agent(s), or he has received any such agent(s) within the previous 30 days, or he is scheduled to receive any such agent(s) in the period up to the planned date for the last study visit.
7. The patient has previously been enrolled in this trial.
8. The patient has previously undergone PET imaging with any PSMA-avid product.
9. The patient has histological evidence of small-cell carcinoma of the prostate.
10. The patient is clinically unstable or requires emergency treatment.
11. The patient has any mental condition rendering him incapable of understanding the nature, scope, and consequences of the trial as set out in the information given to the patient.
18 Years
MALE
No
Sponsors
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ABX advanced biochemical compounds GmbH
INDUSTRY
Responsible Party
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Locations
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CHRU de Nancy
Nancy, , France
Carl Gustav Carus Faculty of Medicine, TUD Dresden
Dresden, , Germany
University Hospital Düsseldorf
Düsseldorf, , Germany
St. Antonius Hospital
Gronau, , Germany
University Hospital Hamburg-Eppendorf
Hamburg, , Germany
University Hospital Leipzig
Leipzig, , Germany
Klinikum rechts der Isar, TUM
München, , Germany
University Hospital Münster
Münster, , Germany
Universitätsmedizin Rostock
Rostock, , Germany
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
Meldola, , Italy
IRCCS Ospedale Sacro Cuore-Don Calabria
Verona, , Italy
The University of Osaka Hospital
Osaka, , Japan
National Cancer Center
Tokyo, , Japan
CWZ
Nijmegen, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Hospital Del Mar
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Vithas Valencia 9 de Octubre
Valencia, , Spain
Countries
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Central Contacts
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Other Identifiers
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EAGLE-i
Identifier Type: -
Identifier Source: org_study_id
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