Clinical trial NCT03609528: CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies
Official title: CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2018-08-01
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Incidence of Infection
timeFrame: 30 days post biopsy
Secondary outcomes:
measure: Patient reported pain score
timeFrame: 30 days post biopsy
measure: Biological functions post biopsy
timeFrame: 30 days post biopsy
measure: Patient willingness to have a repeat biopsy
timeFrame: 30 days post biopsy
Other outcomes:
measure: Clinician Perception
timeFrame: 1 day
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Study officials:
References: