Prostate CancerCAMPROBENCT02375035
Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer
An observational study of Prostate Cancer and Prostate Biopsy, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of undertaking prostate biopsy as part of their clinical management. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Biopsy
- What is being tested?
- CAMPROBE
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have had a standard biopsy and now require a transrectal biopsy as part of their management
Who may be able to join
- Fit and well enough to undergo a repeat prostate biopsy
- Men who have previously had a transrectal ultrasound biopsy of the prostate and due to have a repeat biopsy as part of normal care
- Men on active surveillance
- Men on PSA monitoring
Who cannot join
- Contraindication for a repeat prostate biopsy
- Contraindication for a transperineal prostate biopsies
- Previous perineal or anal surgery
- MRI suggesting anterior lesion or extra capsular disease
- MRI suggesting lesion that needs fusion image targeting
- Unable to lie down and with legs in a stirrup for at least 45 minutes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Stephen Kelleher, +44 1223 217418, r&denquiries@addenbrookes.nhs.uk
About this study
To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of undertaking prostate biopsy as part of their clinical management.
Read the detailed description
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.
- Conditions
- Prostate Cancer, Prostate Biopsy
- Being tested
- CAMPROBE
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMPROBEDevice
To assess patient's experience and complications of the CAMPROBE biopsy needle and compare the results with known published outcomes from standard transrectal biopsies
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score assessment of CAMPROBE biopsy procedure
Measured using a 10 point visual pain score tool and a point based structured questionnaire
Measured: 3 weeks
Patient reported adverse events related to CAMPROBE biopsy
Point based structured questionnaire assessment of adverse events after biopsy
Measured: 3 weeks
Patient perception and acceptance of CAMPROBE biopsy
Point based structured questionnaire including willingness to recommend to a friend
Measured: 3 weeks
Secondary outcomes (2)
Deterioration in urinary function after CAMPROBE biopsy
Measurement of urinary function after the procedure using a structured questionnaire
Measured: 3 weeks
Deterioration in sexual function after CAMPROBE biopsy
Measurement of urinary function after the procedure using a structured questionnaire
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent Gnanapragasam, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Vincent Gnanapragasam, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375035
- Sponsor's protocol ID
- AO93224
- Acronym
- CAMPROBE
- Status last verified
- Feb 2015
- First submitted
- 19 Feb 2015
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer
- ClinicalTrials.gov ID
- NCT02375035
- Acronym / sponsor ID
- CAMPROBE / AO93224
- Conditions
- Prostate Cancer, Prostate Biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of undertaking prostate biopsy as part of their clinical management.
Detailed description
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have had a standard biopsy and now require a transrectal biopsy as part of their management
Key inclusion criteria (4 listed)
- Fit and well enough to undergo a repeat prostate biopsy
- Men who have previously had a transrectal ultrasound biopsy of the prostate and due to have a repeat biopsy as part of normal care
- Men on active surveillance
- Men on PSA monitoring
Key exclusion criteria (6 listed)
- Contraindication for a repeat prostate biopsy
- Contraindication for a transperineal prostate biopsies
- Previous perineal or anal surgery
- MRI suggesting anterior lesion or extra capsular disease
- MRI suggesting lesion that needs fusion image targeting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAMPROBETo assess patient's experience and complications of the CAMPROBE biopsy needle and compare the results with known published outcomes from standard transrectal biopsies | Device | – |
Primary outcome
Pain score assessment of CAMPROBE biopsy procedure
Time frame: 3 weeks
Measured using a 10 point visual pain score tool and a point based structured questionnaire
Patient reported adverse events related to CAMPROBE biopsy
Time frame: 3 weeks
Point based structured questionnaire assessment of adverse events after biopsy
Patient perception and acceptance of CAMPROBE biopsy
Time frame: 3 weeks
Point based structured questionnaire including willingness to recommend to a friend
2 secondary outcomes
Deterioration in urinary function after CAMPROBE biopsy
Time frame: 3 weeks
Deterioration in sexual function after CAMPROBE biopsy
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Gnanapragasam principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Biopsy, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Gnanapragasam (+44 1223 348363, vjg29@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score assessment of CAMPROBE biopsy procedure (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.