Prostate Cancer Clinical Trial
— CAMPROBEOfficial title:
Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer
To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of undertaking prostate biopsy as part of their clinical management.
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge University Hospitals NHS Foundation Trust | Cambridge |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust |
United Kingdom,
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 |
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