CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies (CamPROBE)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CamPROBE
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
To be included in the clinical investigation the participant must:
- Have given written informed consent to participate
- Be aged 18 years and over
- Be suitable for a prostate biopsy and clinically due to have a biopsy for diagnostic or surveillance purposes
- Be willing and able to comply with scheduled visits and completion of study questionnaires
Exclusion Criteria:
The presence of any of the following will preclude participant inclusion:
- Contraindication to a prostate biopsy
- Previous perineal or anal surgery
- Unable to lie down with legs in a stirrup for at least 45 minutes, as assessed by a clinician
Sites / Locations
- Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CamPROBE biopsy method
Arm Description
To be completed
Outcomes
Primary Outcome Measures
Incidence of Infection
Changes in incidence of infection as measured using patient self-reported Follow-Up Questionnaires and telephone assessments.
Secondary Outcome Measures
Patient reported pain score
Patient reported pain scores as measured using patient self-reported questionnaires.
Biological functions post biopsy
Patient biological functions as measured using patient self-reported questionnaires
Patient willingness to have a repeat biopsy
Patients' willingness to have a repeat biopsy as measured using patient self-reported questionnaires
Full Information
NCT ID
NCT03609528
First Posted
June 6, 2018
Last Updated
December 6, 2019
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
University of Cambridge
1. Study Identification
Unique Protocol Identification Number
NCT03609528
Brief Title
CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies
Acronym
CamPROBE
Official Title
CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
October 2, 2019 (Actual)
Study Completion Date
October 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborators
University of Cambridge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The CamPROBE study investigates the rate of infective complications using the Cambridge Prostate Biopsy Device method of local anaesthetic transperineal prostate biopsies.
Detailed Description
The current method for diagnosing prostate cancer requires a biopsy needle to pass through the bowel wall to reach the prostate. Bacteria in the bowel inevitably enter the urinary system and blood stream. A significant number of men develop infections despite preventative antibiotics (1 in 10 develop fevers/shivers and 1-2 in 100 get a life-threatening infection). It is crucial we find a safer biopsy method for suspected prostate cancer as over 1 million rectal biopsies occur each year.
A safer alternative device was developed, performed under local anaesthetic using the transperineal route: CamPROBE (Cambridge Prostate Biopsy Device). CamPROBE biopsies are taken through the perineum (the area under the testicles), so there is no infection risk, and it's just as good at diagnosing prostate cancer. This investigation progresses from a prototype to a disposable, single use device that any UK hospital can use. The study will assess CamPROBE's ability to reduce infections from prostate biopsies and its usability as an alternative to the current standard biopsies.
Men recommended to undergo a prostate biopsy will be eligible for this multi-centre study. For each patient, the study will take approximately 30 days, consisting of: recruitment, 1 day for the procedure (replaces the standard biopsy pathway) and questionnaires on day 1, 7 and 30. This timeframe will not introduce delays in the patients' normal standard care pathway. Patients will have a transperineal biopsy with CamPROBE instead of the current transrectal method. Biopsy samples will be treated the same as standard procedure. Patients' acceptability of the procedure and complications will be measured using patient self-reported questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CamPROBE biopsy method
Arm Type
Experimental
Arm Description
To be completed
Intervention Type
Device
Intervention Name(s)
CamPROBE
Intervention Description
To be completed
Primary Outcome Measure Information:
Title
Incidence of Infection
Description
Changes in incidence of infection as measured using patient self-reported Follow-Up Questionnaires and telephone assessments.
Time Frame
30 days post biopsy
Secondary Outcome Measure Information:
Title
Patient reported pain score
Description
Patient reported pain scores as measured using patient self-reported questionnaires.
Time Frame
30 days post biopsy
Title
Biological functions post biopsy
Description
Patient biological functions as measured using patient self-reported questionnaires
Time Frame
30 days post biopsy
Title
Patient willingness to have a repeat biopsy
Description
Patients' willingness to have a repeat biopsy as measured using patient self-reported questionnaires
Time Frame
30 days post biopsy
Other Pre-specified Outcome Measures:
Title
Clinician Perception
Description
Clinician perception of the device and the performance of the CamPROBE assessed using Clinical Performance Assessment questionnaire
Time Frame
1 day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be included in the clinical investigation the participant must:
Have given written informed consent to participate
Be aged 18 years and over
Be suitable for a prostate biopsy and clinically due to have a biopsy for diagnostic or surveillance purposes
Be willing and able to comply with scheduled visits and completion of study questionnaires
Exclusion Criteria:
The presence of any of the following will preclude participant inclusion:
Contraindication to a prostate biopsy
Previous perineal or anal surgery
Unable to lie down with legs in a stirrup for at least 45 minutes, as assessed by a clinician
Facility Information:
Facility Name
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies
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