Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer
CAMPROBE
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 19, 2015
CompletedFirst Posted
Study publicly available on registry
March 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMarch 2, 2015
February 1, 2015
11 months
February 19, 2015
February 24, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Pain score assessment of CAMPROBE biopsy procedure
Measured using a 10 point visual pain score tool and a point based structured questionnaire
3 weeks
Patient reported adverse events related to CAMPROBE biopsy
Point based structured questionnaire assessment of adverse events after biopsy
3 weeks
Patient perception and acceptance of CAMPROBE biopsy
Point based structured questionnaire including willingness to recommend to a friend
3 weeks
Secondary Outcomes (2)
Deterioration in urinary function after CAMPROBE biopsy
3 weeks
Deterioration in sexual function after CAMPROBE biopsy
3 weeks
Interventions
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 Criteria
Subjects who have had a standard biopsy and now require a transrectal biopsy as part of their management
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Gnanapragasam
University of Cambridge
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer in Uro-oncology and Consultant Urological Surgeon
Study Record Dates
First Submitted
February 19, 2015
First Posted
March 2, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2015
Study Completion
September 1, 2019
Last Updated
March 2, 2015
Record last verified: 2015-02