Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/10/2012
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

Mr Simon F Brewster

ORCID ID

Contact details

Department of Urology
Churchill Hospital
Churchill Drive
Headington
Oxford
OX3 7LJ
United Kingdom
+44 (0)1865 225717

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0176127662

Study information

Scientific title

Acronym

Study hypothesis

TRUS biopsy is the technique of choice for the diagnosis of carcinoma of the prostate (CaP), particularly for early stage tumours. The number of procedures is likely to escalate in the future. The procedure is performed in an outpatient setting without sedation, and without topical analgesia. However, many patients regard the uncomfortable nature of anal distension on the introduction of the rectal ultrasound probe as the most distressing feature of the procedure, and we hope that this can be alleviated with topical GTN (topical glyceryl trinitrate) paste.

Patients will either complete the study by undergoing biopsy with GTN or control paste or withdraw and require inhaled nitrous oxide/general anaesthetic. We hope to recruit 100 patients.

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer: Prostate

Intervention

Glyceryl trinitrate (GTN) or control paste

Intervention type

Drug

Phase

Not Specified

Drug names

topical glyceryl trinitrate

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2003

Overall trial end date

01/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2003

Recruitment end date

01/05/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Urology
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Oxford Radcliffe Hospitals 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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15643191

Publication citations

  1. Results

    Rochester MA, LE Monnier K, Brewster SF, A double-blind, randomized, controlled trial of topical glyceryl trinitrate for transrectal ultrasound guided prostate biopsy., J. Urol., 2005, 173, 2, 418-420, doi: 10.1097/01.ju.0000149872.35473.cb.

Additional files

Editorial Notes