Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
23/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes