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

Phase 2

• Conditions: Prostate Cancer
• Interventions: Drug: 68Ga-NOTA-AE105

• Registration Number: NCT03307460
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-10-06
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-11
• Study Start: 2017-11-21
• Primary Completion: 2019-10-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-23
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
uPAR PET/MRI	68Ga-NOTA-AE105	68Ga-NOTA-AE105 is injected once for performing a PET/MRI scan

Primary Outcome Measures

Name	Time	Method
Correlation with Gleason Score	3 months after PET/MRI	Correlate the uptake of 68Ga-NOTA-AE105 with Gleason Score obtained from biopsy material.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark