Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer (CAMPROBE)

February 24, 2015 updated by: Vincent Gnanapragasam, Cambridge University Hospitals NHS Foundation Trust

To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of undertaking prostate biopsy as part of their clinical management.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Device: CAMPROBE

Detailed Description

To assess patient's experience and complications of the CAMPROBE and compare the results with known published outcomes from standard transrectal biopsies .

To use data from the pilot study to determine the feasibility of a randomised trial comparing CAMPROBE with the current standard method of prostate biopsies.

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - Cambridge, United Kingdom, CB2 0QQ
    - Recruiting
    - Cambridge University Hospitals NHS Foundation Trust
    - Contact:
      
      Stephen Kelleher
      
      Phone Number: +44 1223 217418
      
      Email: r&denquiries@addenbrookes.nhs.uk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Subjects who have had a standard biopsy and now require a transrectal biopsy as part of their management

Description

Inclusion Criteria:

Fit and well enough to undergo a repeat prostate biopsy
Men who have previously had a transrectal ultrasound biopsy of the prostate and due to have a repeat biopsy as part of normal care
Men on active surveillance
Men on PSA monitoring

Exclusion Criteria:

Contraindication for a repeat prostate biopsy
Contraindication for a transperineal prostate biopsies
Previous perineal or anal surgery
MRI suggesting anterior lesion or extra capsular disease
MRI suggesting lesion that needs fusion image targeting
Unable to lie down and with legs in a stirrup for at least 45 minutes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score assessment of CAMPROBE biopsy procedure Time Frame: 3 weeks	Measured using a 10 point visual pain score tool and a point based structured questionnaire	3 weeks
Patient reported adverse events related to CAMPROBE biopsy Time Frame: 3 weeks	Point based structured questionnaire assessment of adverse events after biopsy	3 weeks
Patient perception and acceptance of CAMPROBE biopsy Time Frame: 3 weeks	Point based structured questionnaire including willingness to recommend to a friend	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deterioration in urinary function after CAMPROBE biopsy Time Frame: 3 weeks	Measurement of urinary function after the procedure using a structured questionnaire	3 weeks
Deterioration in sexual function after CAMPROBE biopsy Time Frame: 3 weeks	Measurement of urinary function after the procedure using a structured questionnaire	3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Investigators

Principal Investigator: Vincent Gnanapragasam, University of Cambridge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Estimate)