SURF: Ultrasound for Detection of Prostate Cancer

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05736094
• Collaborator: Norwegian University of Science and Technology (Other), University of Oslo (Other), The Research Council of Norway (Other)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 16.5
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: SURF	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Dual-frequency Ultrasound for Detection of Prostate Cancer
• Actual Study Start Date: Feb 14, 2023
• Anticipated Primary Completion Date: Feb 28, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Dual-frequency ultrasound Dual-frequency ultrasound for detection of prostate cancer	Device: SURF; Dual-frequency ultrasound

Outcome Measures

Primary Outcome Measures

1. Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer. [1 day]

   Sensitivity and specificity outcome measures

2. Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer. [1 day]

   Comparing dual-frequency ultrasound, shear waves ultrasound, CEUS to MRI and histopathological findings

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 years onwards

• Signed written informed consent to perform rectal and transperineal ultrasound

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	0379

Sponsors and Collaborators

• Oslo University Hospital
• Norwegian University of Science and Technology
• University of Oslo
• The Research Council of Norway

Investigators

• Principal Investigator: Wolfgang Lilleby, MD PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wolfgang Lilleby, Principal Investigator, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT05736094
• Other Study ID Numbers: 248446; 313778
• First Posted: Feb 21, 2023
• Last Update Posted: Feb 28, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Feb 28, 2023