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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: CamPROBE

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CamPROBE biopsy method; To be completed	Device: CamPROBE; To be completed

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Perception	Clinician perception of the device and the performance of the CamPROBE assessed using Clinical Performance Assessment questionnaire	1 day

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: University of Cambridge

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2019
• Primary Completion (ACTUAL): October 2, 2019
• Study Completion (ACTUAL): October 2, 2019

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (ACTUAL): August 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CamPROBE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No