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

November 20, 2020 updated by: Marie Øbro Fosbøl, Rigshospitalet, Denmark

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: uPAR PET/MRI
68Ga-NOTA-AE105 is injected once for performing a PET/MRI scan
Drug: 68Ga-NOTA-AE105
PET/MRI scan
Other Names:
  • PET/MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation with Gleason Score
Time Frame: 3 months after PET/MRI
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
Time Frame: 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.
3 years from PET/MRI
Diagnostic accuracy in staging lymph nodes
Time Frame: 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
3 months from PET/MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Marie Ø Fosboel, MD, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2017

Primary Completion (Actual)

October 11, 2019

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

October 6, 2017

First Submitted That Met QC Criteria

October 6, 2017

First Posted (Actual)

October 11, 2017

Study Record Updates

Last Update Posted (Actual)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK-2017-PC-1
  • 2017-002276-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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