Prostate CancerSURFNCT05736094
Ultrasound for Detection of Prostate Cancer
A study testing SURF in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SURF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNorway
- Study dates
- 14 Feb 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years onwards
- Signed written informed consent to perform rectal and transperineal ultrasound
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual-frequency Ultrasound for Detection of Prostate Cancer
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- SURF
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SURFDevice
Dual-frequency ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Dual-frequency ultrasound | Other | Dual-frequency ultrasound for detection of prostate cancer Receives: Device: SURF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
Sensitivity and specificity outcome measures
Measured: 1 day
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start14 Feb 2023
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University of Oslo, The Research Council of Norway
- Responsible party
- Principal investigator, Wolfgang Lilleby, Oslo University Hospital
- Investigators
- Wolfgang Lilleby, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736094
- Sponsor's protocol ID
- 248446
- Other IDs
- 313778
- Acronym
- SURF
- Status last verified
- Apr 2024
- First submitted
- 10 Feb 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-frequency Ultrasound for Detection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT05736094
- Acronym / sponsor ID
- SURF / 248446
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University of Oslo, The Research Council of Norway
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual-frequency ultrasound | Other | Device: SURFDual-frequency ultrasound for detection of prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years onwards
- Signed written informed consent to perform rectal and transperineal ultrasound
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SURFDual-frequency ultrasound | Device | Dual-frequency ultrasound |
Primary outcome
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
Time frame: 1 day
Sensitivity and specificity outcome measures
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
Time frame: 1 day
Comparing dual-frequency ultrasound, shear waves ultrasound, CEUS to MRI and histopathological findings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Lilleby, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SURF in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer. (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.