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

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

68Ga-NOTA-AE105

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

uPAR PET/MRI

Arm Description

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

Outcomes

Primary Outcome Measures

Correlation with Gleason Score

Correlate the uptake of 68Ga-NOTA-AE105 with Gleason Score obtained from biopsy material.

Secondary Outcome Measures

Prognostic value

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

Evaluate the diagnostic accuracy of uPAR PET/MRI in identifying regional lymph node metastases in patients with newly diagnosed prostate cancer

Full Information

NCT ID

NCT03307460

First Posted

October 6, 2017

Last Updated

November 20, 2020

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT03307460

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 21, 2017 (Actual)

Primary Completion Date

October 11, 2019 (Actual)

Study Completion Date

April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

uPAR PET/MRI

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

68Ga-NOTA-AE105

Other Intervention Name(s)

PET/MRI

Intervention Description

PET/MRI scan

Primary Outcome Measure Information:

Title

Correlation with Gleason Score

Description

Correlate the uptake of 68Ga-NOTA-AE105 with Gleason Score obtained from biopsy material.

Time Frame

3 months after PET/MRI

Secondary Outcome Measure Information:

Title

Prognostic value

Description

Evaluate the prognostic value of uPAR PET/MRI in patients with prostate cancer either undergoing therapy with curative intent or active surveillance.

Time Frame

3 years from PET/MRI

Title

Diagnostic accuracy in staging lymph nodes

Description

Evaluate the diagnostic accuracy of uPAR PET/MRI in identifying regional lymph node metastases in patients with newly diagnosed prostate cancer

Time Frame

3 months from PET/MRI

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie Ø Fosboel, MD

Organizational Affiliation

Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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