Prostate Biopsy, Prostate Cancer
Conditions
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.
Interventions
DEVICECAMPROBE
To assess patient's experience and complications of the CAMPROBE biopsy needle and compare the results with known published outcomes from standard transrectal biopsies
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Contacts
Primary ContactVincent Gnanapragasam
Backup ContactAnne George
Outcome results
None listed