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

Prostate Cancer Clinical Trial

— CAMPROBE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02375035
• Other study ID #: AO93224
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2015
• Last updated: February 24, 2015
• Start date: January 2015
• Est. completion date: September 2019

Study information

• Verified date: February 2015
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Vincent Gnanapragasam
• Phone: +44 1223 348363
• Email: vjg29[@]cam.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2019
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Biopsy
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score assessment of CAMPROBE biopsy procedure	Measured using a 10 point visual pain score tool and a point based structured questionnaire	3 weeks	No
Primary	Patient reported adverse events related to CAMPROBE biopsy	Point based structured questionnaire assessment of adverse events after biopsy	3 weeks	No
Primary	Patient perception and acceptance of CAMPROBE biopsy	Point based structured questionnaire including willingness to recommend to a friend	3 weeks	No
Secondary	Deterioration in urinary function after CAMPROBE biopsy	Measurement of urinary function after the procedure using a structured questionnaire	3 weeks	No
Secondary	Deterioration in sexual function after CAMPROBE biopsy	Measurement of urinary function after the procedure using a structured questionnaire	3 weeks	No