NCT03609528

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	CamPROBE	To be completed

Timeline

• Start date: 2019-02-15
• Primary completion: 2019-10-02
• Completion: 2019-10-02
• First posted: 2018-08-01
• Last updated: 2019-12-09

Locations

1 site across 1 country: United Kingdom