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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03307460
Collaborator
(none)
52
Enrollment
1
Location
1
Arm
52.3
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Phase II Trial: uPAR-PET/MR in Patients With Newly Diagnosed Prostate Cancer; Non-invasive Characterization of Tumor Aggressiveness
Actual Study Start Date :
Nov 21, 2017
Actual Primary Completion Date :
Oct 11, 2019
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marie Øbro Fosbøl, Medical doctor, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT03307460
    Other Study ID Numbers:
    • AK-2017-PC-1
    • 2017-002276-37
    First Posted:
    Oct 11, 2017
    Last Update Posted:
    Nov 23, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Aggression

    Study Results

    No Results Posted as of Nov 23, 2020