Contact information
Type
Scientific
Primary contact
Mr Vinod Nargund
ORCID ID
Contact details
Department of Urology
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
+44 020 8510 7522
vinod.nargund@homerton.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0024108495
Study information
Scientific title
Acronym
Study hypothesis
The use of real time 3-D (4-D ultrasound) guided transrectal biopsy of prostate improves sensitivity and specificity in identifying potential malignant foci in prostate gland compared to conventional 2-D ultrasonography.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cancer: Prostate
Intervention
1.. 4-D ultrasound
2. Standard care
July 2008: trial not started.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Total PSA prostate volume
2. Volume of the tumour
3. PSA Density: PSA X volume
4. Histology of the cores: Gleason grading
5. Doppler findings: Pulsatility index, peak systolic volume, resistance index, flow velocity
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2002
Overall trial end date
31/01/2004
Reason abandoned (if study stopped)
Not started because of lack of funding
Eligibility
Participant inclusion criteria
1. Patients with suspected carcinoma of the prostate, ie raised prostate specific antigen (PSA)
2. Age group 45-70 years
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Total 60 patients, 30 patients in 2-D group, 30 patients in 4-D group
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2002
Recruitment end date
31/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Urology
London
E9 6SR
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Homerton University Hospital NHS Trust (UK)
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
Basic results (scientific)
Publication list