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
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
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
NCT ID
NCT05736094
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
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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