uPAR-PET/MRI in Patients With Prostate Cancer for Evaluation of Tumor Aggressiveness
NCT ID: NCT03307460
Last Updated: 2020-11-23
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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UNKNOWN
PHASE2
52 participants
INTERVENTIONAL
2017-11-21
2022-04-01
Brief Summary
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Detailed Description
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Treatment of localized prostate cancer is based on a risk stratification, where patients are either offered therapy with curative intent - surgery or radiotherapy - or in case of low-risk disease an "active surveillance" strategy can be advised. In active surveillance the disease is monitored by PSA measurement, repeated biopsies and digital rectal examination. Some patients progress during active surveillance to a higher risk classification, which may lead to selection of active therapy.
The aim of this study is to investigate positron emission tomography (PET) with the radiolabelled tracer 68Ga-NOTA-AE105, combined with magnetic resonance imaging (MRI) in patients with newly diagnosed prostate cancer. 68Ga-NOTA-AE105 targets the receptor urokinase-type plasminogen activator receptor (uPAR), which is a known marker for aggressive disease in prostate cancer.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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uPAR PET/MRI
68Ga-NOTA-AE105 is injected once for performing a PET/MRI scan
68Ga-NOTA-AE105
PET/MRI scan
Interventions
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68Ga-NOTA-AE105
PET/MRI scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Capable of understanding written information and giving informed consent
* Planned to enter active surveillance strategy or undergo therapy with curative intent (surgery or radiotherapy)
Exclusion Criteria
* Known allergy to 68-Ga-NOTA-AE105
* Metallic components in the body that contradicts MRI scan
* Severe claustrophobia making the person unable to complete an MRI scan
18 Years
MALE
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Marie Øbro Fosbøl
Medical doctor
Principal Investigators
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Marie Ø Fosboel, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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Other Identifiers
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2017-002276-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AK-2017-PC-1
Identifier Type: -
Identifier Source: org_study_id