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Capture of Prostatic Trans-rectal Ultrasound Scans for Research (CAPTURE)

Primary Purpose

Prostate Cancer, Prostate Neoplasm

Status
Suspended
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transrectal ultrasound scan of prostate
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prostate Cancer focused on measuring Transperineal biopsy, Prostate cancer, Transrectal ultrasound, Fusion biopsy techniques

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Addenbrookes Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study arm

Arm Description

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

Outcomes

Primary Outcome Measures

Prostate size
Ultrasound images and videos of the prostate will be captured to measure the length, width and depth of the prostate on ultrasound. The measurements will be in millimeters (mm). This will be taken at a single time-point at the time of general anaesthesia for transperineal biopsy.
Prostate location
Ultrasound images and videos of the prostate will be captured to assess prostate location relative to surrounding structures. Specifically this will mean measuring the distance from the anal verge to the prostate. Unit of measurment is millimeters (mm). This will be taken at a single time-point at the time of general anaesthesia for transperineal biopsy.

Secondary Outcome Measures

Full Information

First Posted
October 13, 2017
Last Updated
July 8, 2020
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
University of Cambridge
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1. Study Identification

Unique Protocol Identification Number
NCT03321864
Brief Title
Capture of Prostatic Trans-rectal Ultrasound Scans for Research
Acronym
CAPTURE
Official Title
Capture of Prostatic Trans-rectal Ultrasound Scans for Research Into Improved Targeted Biopsy Techniques (CAPTURE)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Suspended
Why Stopped
PI has left Trust currently.
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
University of Cambridge

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Neoplasm
Keywords
Transperineal biopsy, Prostate cancer, Transrectal ultrasound, Fusion biopsy techniques

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All available patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Arm Description
All patients recruited to the study (this arm) will have an additional transrectal ultrasound whilst already under GA for TP biopsy.
Intervention Type
Procedure
Intervention Name(s)
Transrectal ultrasound scan of prostate
Intervention Description
Additional transrectal ultrasound whilst already under GA for transperineal biopsy.
Primary Outcome Measure Information:
Title
Prostate size
Description
Ultrasound images and videos of the prostate will be captured to measure the length, width and depth of the prostate on ultrasound. The measurements will be in millimeters (mm). This will be taken at a single time-point at the time of general anaesthesia for transperineal biopsy.
Time Frame
Years 1-5
Title
Prostate location
Description
Ultrasound images and videos of the prostate will be captured to assess prostate location relative to surrounding structures. Specifically this will mean measuring the distance from the anal verge to the prostate. Unit of measurment is millimeters (mm). This will be taken at a single time-point at the time of general anaesthesia for transperineal biopsy.
Time Frame
Years 1-5

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Thurtle
Organizational Affiliation
University of Cambridge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addenbrookes Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Capture of Prostatic Trans-rectal Ultrasound Scans for Research

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