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

• Conditions: Prostate Cancer; Prostate Biopsy

• Registration Number: NCT02375035
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

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

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 Timeline

• Study Start: 2015-01
• Status Verified: 2015-02
• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-24
• Last Update Submitted: 2015-02-24
• Study First Posted: 2015-03-02
• Last Update Posted: 2015-03-02
• Primary Completion: 2015-12
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Deterioration in urinary function after CAMPROBE biopsy	3 weeks	Measurement of urinary function after the procedure using a structured questionnaire
Deterioration in sexual function after CAMPROBE biopsy	3 weeks	Measurement of urinary function after the procedure using a structured questionnaire

Trial Locations

Locations (1)

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom