Condition category
Cancer
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
27/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss S Jervis

ORCID ID

Contact details

Medical Physics
Wellcome Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 6495
r&d@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436146607

Study information

Scientific title

The effect of magnetic resonance imaging localisation of prostate cancer on transrectal ultrasound biopsy detection rate

Acronym

Study hypothesis

To investigate whether localisation information from magnetic resonance imaging (MRI) can be used to improve the accuracy of trans-rectal ultrasound (TRUS) biopsy and thereby improve the detection rate of prostate cancer.

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 below to request a patient information sheet

Condition

Prostate cancer

Intervention

Randomised controlled trial

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Percentage of patients with at least one positive biopsy in each cohort.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

09/02/2004

Overall trial end date

01/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All patients who are to have a transrectal ultrasound (TRUS) biopsy (on a Thursday) to confirm prostate cancer, with an intermediate PSA level (10-19 ng/ml), will be eligible for entry to the study. On average 8 patients undergo TRUS biopsy at Cookridge Hospital per week (divided between Tuesday and Thursday morning sessions). One MRI slot per week (Thursday morning) will be available for the study. All consenting patients will be randomised and one selected for the MRI cohort and all others will form the non-MRI cohort. Assuming at least 2 patients are recruited a week (50%) recruitment rate) the two cohorts (61 patients in each) will be recruited in 61 weeks.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

122

Participant exclusion criteria

1. Unwilling/unable to give informed consent
2. Significant claustrophobia
3. Contra indications to MRI: pacemaker, aneurysm clips, metallic foreign bodies in the eye

Recruitment start date

09/02/2004

Recruitment end date

01/08/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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