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

Cambridge University Hospitals NHS Foundation Trust50 enrolled

Overview

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

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

Conditions

Prostate Cancer Prostate Biopsy

Interventions

CAMPROBEDEVICE

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Pain score assessment of CAMPROBE biopsy procedure

Measured using a 10 point visual pain score tool and a point based structured questionnaire

Time frame: 3 weeks

Patient reported adverse events related to CAMPROBE biopsy

Point based structured questionnaire assessment of adverse events after biopsy

Time frame: 3 weeks

Patient perception and acceptance of CAMPROBE biopsy

Point based structured questionnaire including willingness to recommend to a friend

Time frame: 3 weeks

Secondary Outcomes

Deterioration in urinary function after CAMPROBE biopsy

Measurement of urinary function after the procedure using a structured questionnaire

Time frame: 3 weeks

Deterioration in sexual function after CAMPROBE biopsy

Measurement of urinary function after the procedure using a structured questionnaire

Time frame: 3 weeks

Central Contacts

Vincent Gnanapragasam

CONTACT

+44 1223 348363 vjg29@cam.ac.uk

Anne George

CONTACT

+44 1223 348440 anne.george@addenbrookes.nhs.uk

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.