Capture of Prostatic Trans-rectal Ultrasound Scans for Research

NCT03321864 | Suspended

• 2 other identifiers: A094516228575
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Neoplasm

Keywords

Transperineal biopsy; Prostate cancer; Transrectal ultrasound; Fusion biopsy techniques

Outcome Measures

Primary Outcomes (2)

• 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.

  Years 1-5

• 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.

  Years 1-5

Study Arms (1)

Study arm

EXPERIMENTAL

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

Procedure: Transrectal ultrasound scan of prostate

Interventions

Transrectal ultrasound scan of prostate PROCEDURE

Additional transrectal ultrasound whilst already under GA for transperineal biopsy.

Study arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• University of Cambridge: collaborator

Study Sites (1)

Addenbrookes Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• David Thurtle

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Associate and Honorary Urology Registrar

Model Details: All available patients

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 26, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)