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Ultrasound for Detection of Prostate Cancer (SURF)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
SURF
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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: Age 18 years onwards Signed written informed consent to perform rectal and transperineal ultrasound Exclusion Criteria: N/A

Sites / Locations

  • Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dual-frequency ultrasound

Arm Description

Dual-frequency ultrasound for detection of prostate cancer

Outcomes

Primary Outcome Measures

Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
Sensitivity and specificity outcome measures
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
Comparing dual-frequency ultrasound, shear waves ultrasound, CEUS to MRI and histopathological findings

Secondary Outcome Measures

Full Information

First Posted
February 10, 2023
Last Updated
February 24, 2023
Sponsor
Oslo University Hospital
Collaborators
Norwegian University of Science and Technology, University of Oslo, The Research Council of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT05736094
Brief Title
Ultrasound for Detection of Prostate Cancer
Acronym
SURF
Official Title
Dual-frequency Ultrasound for Detection of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian University of Science and Technology, University of Oslo, The Research Council of Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
Detailed Description
Prospectively recruited patients before prostatectomy and/or definitive radiotherapy will be included in the study. Dual-frequency ultrasound imaging will be compared to standard transrectal ultrasound and MRI. Imaging of primary tumor with dual-frequency ultrasound technology including the use of microbubble contrast-media. A prostate biopsy and blood sample will be taken from each patient, for histopathology and explorative biomarkers.

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
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual-frequency ultrasound
Arm Type
Other
Arm Description
Dual-frequency ultrasound for detection of prostate cancer
Intervention Type
Device
Intervention Name(s)
SURF
Intervention Description
Dual-frequency ultrasound
Primary Outcome Measure Information:
Title
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
Description
Sensitivity and specificity outcome measures
Time Frame
1 day
Title
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
Description
Comparing dual-frequency ultrasound, shear waves ultrasound, CEUS to MRI and histopathological findings
Time Frame
1 day

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only men will be included as prostate cancer does not appear in women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years onwards Signed written informed consent to perform rectal and transperineal ultrasound Exclusion Criteria: N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise N Torpen, MSc
Phone
004790864581
Email
linyto@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfgang Lilleby, MD PhD
Phone
004722934189
Email
WLL@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Lilleby, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Lilleby, MD PhD
First Name & Middle Initial & Last Name & Degree
Lise Torpen, MSc
First Name & Middle Initial & Last Name & Degree
Wolfgang Lilleby, MD PhD

12. IPD Sharing Statement

Learn more about this trial

Ultrasound for Detection of Prostate Cancer

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