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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03307460
• Other study ID #: AK-2017-PC-1
• Secondary ID: 2017-002276-37
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 21, 2017
• Est. completion date: April 1, 2022

Study information

• Verified date: November 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: April 1, 2022
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 68Ga-NOTA-AE105
PET/MRI scan

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation with Gleason Score	Correlate the uptake of 68Ga-NOTA-AE105 with Gleason Score obtained from biopsy material.	3 months after PET/MRI
Secondary	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
Secondary	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