CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies

Study Overview
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Brief Summary
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The CamPROBE study investigates the rate of infective complications using the Cambridge Prostate Biopsy Device method of local anaesthetic transperineal prostate biopsies.

Detailed Description
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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.

Official Title
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CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: CamPROBE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CamPROBE biopsy method<br>To be completed | Device: CamPROBE<br>* To be completed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Infection | Changes in incidence of infection as measured using patient self-reported Follow-Up Questionnaires and telephone assessments. | 30 days post biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported pain score | Patient reported pain scores as measured using patient self-reported questionnaires. | 30 days post biopsy | 
| Biological functions post biopsy | Patient biological functions as measured using patient self-reported questionnaires | 30 days post biopsy | 
| Patient willingness to have a repeat biopsy | Patients' willingness to have a repeat biopsy as measured using patient self-reported questionnaires | 30 days post biopsy |