Diagnostic Imaging of Bone Metastases in Prostate Cancer Patients

Not Applicable

• Conditions: Prostate Cancer Metastatic to Bone
• Interventions: Diagnostic Test: WB-MRI; Diagnostic Test: Cholin-PET-CT; Diagnostic Test: SPECT-CT; Diagnostic Test: PSMA-PET-CT

• Registration Number: NCT03134261
• Lead Sponsor: Herlev Hospital

Brief Summary

An improved diagnosis of bone metastases in prostate cancer patients can have a significant impact on treatment strategy and probably survival as well.

The primary purpose of the project is to determine the diagnostic accuracy of bone SPECT-CT, choline-PET-CT, PSMA-PET-CT, NaF-PET-CT and Whole-body MRI in the diagnosis of bone metastases in prostate cancer patients.

Detailed Description

The project is a prospective diagnostic test accuracy study. The project takes place at Herlev Hospital and is a collaboration between the Department of Radiology and the Department of Clinical Physiology and Nuclear Medicine.

The investigators want to include 300 prostate cancer patients referred to our standard diagnostic imaging (NaF-PET-CT scan) by the clinicians.

In addition to the standard diagnostic imaging (NaF-PET-CT-scan), two project will be performed on all participants. The project has three arms with the following scanning combinations:

A) Whole-body MRI + SPECT-CT B) Whole-body MRI + Cholin-PET-CT C) Whole-body MRI + PSMA-PET-CT The recruitment of project participants takes place on the day when the patients are undergoing a NaF-PET-CT scan in the course of regular clinical practice at our institution.

All readers are experienced radiologists or specialists in nuclear medicine. Patient identification on each scan will be anonymized and the reader will not have access to clinical and biochemical information or previous imaging studies.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

A subject will be eligible for project participation if he meets all of the following criteria:

• Is either 1) a newly diagnosed prostate cancer patient in clinical suspicion of bone metastases or 2) a previously diagnosed prostate cancer patient in clinical suspicion of progression in the form of bone metastases. The subject must have been referred to the standard diagnostic imaging (18F-NaF-PET-CT) at our institution for bone metastases.
• The prostate cancer diagnosis must be biopsy-proven
• The subject is willing and able to comply with the protocol as judged by the investigator

Exclusion Criteria

A subject will be excluded from the protocol if he meets one or more of the following criteria:

• Has prior malignancy, except for adequately treated basal cell or squamous cell skin cancer
• Has pacemaker or implanted devices (eg. cardiac valves, neurostimulator or insulin pump) that cannot be removed, metal clips/metal prostheses from surgery that are not MRI compatible or metallic foreign bodies in the eye (MRI exclusion criteria)
• Has any condition that places the subject at an unacceptable risk if he undergoes a diagnostic CT-scan (e.g. history of severe allergic reaction to the contrast agent).
• Has severe obesity (>195 kg is the weight limit for the scanner table)
• Has severe claustrophobia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cholin-PET-CT	WB-MRI	The participants will undergo two project scans: WB-MRI and Cholin-PET-CT
Cholin-PET-CT	Cholin-PET-CT	The participants will undergo two project scans: WB-MRI and Cholin-PET-CT
PSMA-PET-CT	WB-MRI	The participants will undergo two project scans: WB-MRI and PSMA-PET-CT
SPECT-CT	SPECT-CT	The participants will undergo two project scans: WB-MRI and SPECT-CT
PSMA-PET-CT	PSMA-PET-CT	The participants will undergo two project scans: WB-MRI and PSMA-PET-CT
SPECT-CT	WB-MRI	The participants will undergo two project scans: WB-MRI and SPECT-CT

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	The two project scans will be performed within a maximum of 30 days from the performance of the NaF-PET-CT scan	Sensitivity and specificity

Trial Locations

Locations (1)

Department of Radioogy/Department of Nuclear Medicine; 🇩🇰 Herlev, Denmark