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

NCT ID: NCT02375035

Last Updated: 2015-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-09-30

Brief Summary

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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

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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

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Prostate Cancer Prostate Biopsy

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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CAMPROBE

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Vincent Gnanapragasam

Lecturer in Uro-oncology and Consultant Urological Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincent Gnanapragasam

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Locations

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Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Vincent Gnanapragasam

Role: CONTACT

+44 1223 348363

Anne George

Role: CONTACT

+44 1223 348440

Facility Contacts

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Stephen Kelleher

Role: primary

+44 1223 217418

Other Identifiers

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AO93224

Identifier Type: -

Identifier Source: org_study_id

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