Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Anesthetics, Local

CamPROBE

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

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.

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

Clinician perception of the device and the performance of the CamPROBE assessed using Clinical Performance Assessment questionnaire

Changes in incidence of infection as measured using patient self-reported Follow-Up Questionnaires and telephone assessments.

Patient reported pain scores as measured using patient self-reported questionnaires.

Patient biological functions as measured using patient self-reported questionnaires

Patients' willingness to have a repeat biopsy as measured using patient self-reported questionnaires

University of Cambridge

Cambridge University Hospitals NHS Foundation Trust

To assess patient's experience and complications of the CAMPROBE biopsy needle and compare the results with known published outcomes from standard transrectal biopsies

CAMPROBE

Vincent Gnanapragasam

Anne George

Stephen Kelleher

To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of undertaking prostate biopsy as part of their clinical management.

To assess patient's experience and complications of the CAMPROBE and compare the results with known published outcomes from standard transrectal biopsies .

To use data from the pilot study to determine the feasibility of a randomised trial comparing CAMPROBE with the current standard method of prostate biopsies.

Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer

Measured using a 10 point visual pain score tool and a point based structured questionnaire

Point based structured questionnaire assessment of adverse events after biopsy

Point based structured questionnaire including willingness to recommend to a friend

Measurement of urinary function after the procedure using a structured questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies	NCT03609528	Prostate Cancer	CamPROBE	18 Years -	Cambridge University Hospitals NHS Foundation Trust
CamPROBE: Developing a Safer and Simple Device for Local Anaesthetic Transperineal Prostate Biopsies	NCT03609528	Prostate Cancer	CamPROBE	18 Years -	Cambridge University Hospitals NHS Foundation Trust
Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer	NCT02375035	Prostate Cancer Prostate Biopsy	CAMPROBE	18 Years - 85 Years	Cambridge University Hospitals NHS Foundation Trust

Spots Global Cancer Trial Database for camprobe

Every month we try and update this database with for camprobe cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for camprobe

Every month we try and update this database with for camprobe cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for camprobe cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.