uPAR-PET/MRI in Patients With Prostate Cancer for Evaluation of Tumor Aggressiveness

Study Overview
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Brief Summary
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Prospective study to evaluate the value of uPAR-targeted PET/MR scan using the tracer 68Ga-NOTA-AE105 in patients with newly diagnosed prostate cancer

Detailed Description
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Prostate cancer is one of the most frequent types of cancer in men. The characteristics of the disease varies significantly among patients where some have an indolent type of cancer, from which they will never experience symptoms while others have highly aggressive malignant disease that requires prompt therapeutic action. 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.

Official Title
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Phase II Trial: uPAR-PET/MR in Patients With Newly Diagnosed Prostate Cancer; Non-invasive Characterization of Tumor Aggressiveness

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 68Ga-NOTA-AE105


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically verified prostate cancer 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: Obesity (Body weight over 140 kg) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: uPAR PET/MRI<br>68Ga-NOTA-AE105 is injected once for performing a PET/MRI scan | Drug: 68Ga-NOTA-AE105<br>* PET/MRI scan<br>* Other names: PET/MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with Gleason Score | Correlate the uptake of 68Ga-NOTA-AE105 with Gleason Score obtained from biopsy material. | 3 months after PET/MRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic value | Evaluate the prognostic value of uPAR PET/MRI in patients with prostate cancer either undergoing therapy with curative intent or active surveillance. | 3 years from PET/MRI | 
| Diagnostic accuracy in staging lymph nodes | Evaluate the diagnostic accuracy of uPAR PET/MRI in identifying regional lymph node metastases in patients with newly diagnosed prostate cancer | 3 months from PET/MRI |