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

Rigshospitalet

Status and phase: Unknown; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: 68Ga-NOTA-AE105

Study type: Interventional

Funder types: Other

Identifiers

NCT03307460

AK-2017-PC-1

2017-002276-37 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 52 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

uPAR PET/MRI

Experimental group

Description:

68Ga-NOTA-AE105 is injected once for performing a PET/MRI scan

Treatment:

Drug: 68Ga-NOTA-AE105