Contact information
Type
Scientific
Primary contact
Mr Rahul Mistry
ORCID ID
Contact details
Urology Dept
Ward M2
Clatterbridge Hospital
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom
+44 (0)7967339014
rahulmistry1@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0280190231
Study information
Scientific title
The effect of needle thickness on the diagnosis of prostate cancer
Acronym
Study hypothesis
1. To determine if using smaller needles to biopsy the prostate provides tissue that is equally accurate for histopathological examination.
2. To analyse the post-operative pain perception following local anaesthetic infiltration or sedation prostrate biopsies.
3. To determine if there are any post-operative complications or erectile dysfunction following prostrate biopsies.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cancer: Prostate
Intervention
Double blind binary randomization to either large needle TRUS biopsy or small needle TRUS biopsy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Pre-op erectile dysfunction questionnaire
2. Post-op pain evaluation
3. Complication & ED questionnaire
4. Prostate histopathology
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2006
Overall trial end date
01/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
75-100 consecutive men undergoing TRUS prostate biopsies for investigation into a raised PSA level &/or an abnormal digital rectal examination (DRE)
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
100
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/12/2006
Recruitment end date
01/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clatterbridge Hospital
Wirral
CH63 4JY
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Wirral Hospitals NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary