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

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ClinicalTrials.gov Identifier: NCT02375035
Recruitment Status : Unknown
Verified February 2015 by Vincent Gnanapragasam, Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : March 2, 2015
Last Update Posted : March 2, 2015
Sponsor:
Information provided by (Responsible Party):
Vincent Gnanapragasam, Cambridge University Hospitals NHS Foundation Trust

Brief 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.

Condition or disease Intervention/treatment
Prostate Cancer Prostate Biopsy Device: CAMPROBE

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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Time Perspective: Prospective
Official Title: Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer
Study Start Date : January 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: 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


Primary Outcome Measures :
  1. 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

  2. Patient reported adverse events related to CAMPROBE biopsy [ Time Frame: 3 weeks ]
    Point based structured questionnaire assessment of adverse events after biopsy

  3. Patient perception and acceptance of CAMPROBE biopsy [ Time Frame: 3 weeks ]
    Point based structured questionnaire including willingness to recommend to a friend


Secondary Outcome Measures :
  1. Deterioration in urinary function after CAMPROBE biopsy [ Time Frame: 3 weeks ]
    Measurement of urinary function after the procedure using a structured questionnaire

  2. Deterioration in sexual function after CAMPROBE biopsy [ Time Frame: 3 weeks ]
    Measurement of urinary function after the procedure using a structured questionnaire



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects who have had a standard biopsy and now require a transrectal biopsy as part of their management
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375035


Contacts
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Contact: Vincent Gnanapragasam +44 1223 348363 vjg29@cam.ac.uk
Contact: Anne George +44 1223 348440 anne.george@addenbrookes.nhs.uk

Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Stephen Kelleher    +44 1223 217418    r&denquiries@addenbrookes.nhs.uk   
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Vincent Gnanapragasam University of Cambridge

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Responsible Party: Vincent Gnanapragasam, Lecturer in Uro−oncology and Consultant Urological Surgeon, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02375035     History of Changes
Other Study ID Numbers: AO93224
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: March 2, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases