Capture of Prostatic Trans-rectal Ultrasound Scans for Research

NCT ID: NCT03321864

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-12-31

Brief Summary

Through this study the investigators seek to build up a repository of prostate ultrasonography videos and prostate MRI scans to enable research into novel anatomical registration techniques. These data will facilitate the development of improved technology that enables targeting of tumours seen on MRI using free-hand biopsy techniques, without the need for a gantry or overlaid perineal grid.

Detailed Description

The purpose of this study is to explore whether mathematical and computational modelling techniques can be used to enable anatomical based real-time image registration for guiding prostate biopsies. This would lead to the ability to perform free-hand trans-perineal biopsy without the need for supporting gantries or a biopsy grid placed over the perineum. This will significantly decrease costs of trans-perineal biopsy, reduce the number of puncture sites through the perineal skin - reducing pain and bleeding - and reduce the procedure time. Alongside locally developed local-anaesthetic transperineal biopsy techniques it will allow targeted biopsy to be taken in the outpatient setting, improving patient convenience, and helping health services to meet growing demands on targeted biopsies.

The investigators aim to create a new method of mapping the prostate using free-hand ultrasound, without any additional physical equipment. This may require collaborations with approved International groups with particular skills in relevant mathematical or engineering techniques.

Conditions

Prostate Cancer; Prostate Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Study arm

All patients recruited to the study (this arm) will have an additional transrectal ultrasound whilst already under GA for TP biopsy.

Group Type: EXPERIMENTAL

Transrectal ultrasound scan of prostate

Intervention Type: PROCEDURE

Additional transrectal ultrasound whilst already under GA for transperineal biopsy.

Interventions

Transrectal ultrasound scan of prostate

Additional transrectal ultrasound whilst already under GA for transperineal biopsy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subjects undergoing trans-perineal prostate biopsy under general anaesthesia who have had an MRI of their prostate within the preceding 12 months.
• Male.
• Age 18-100.

Exclusion Criteria

• Those unable to provide informed consent.
• Any medical condition, vital sign or laboratory value that, in the opinion of the investigator or responsible anaesthetist makes any prolongation of general anaesthesia unsafe to the participant.
• Patients unable to have an MRI

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Cambridge

OTHER

Sponsor Role: collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

David Thurtle

Clinical Research Associate and Honorary Urology Registrar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Thurtle

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Locations

Addenbrookes Hospital

Cambridge, Cambridgeshire, United Kingdom

Countries

United Kingdom

Other Identifiers

228575

Identifier Type: REGISTRY

Identifier Source: secondary_id

A094516

Identifier Type: -

Identifier Source: org_study_id