Condition category
Cancer
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
08/09/2015
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

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 below 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

No exclusion criteria

Recruitment start date

01/12/2006

Recruitment end date

01/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Urology Dept, Ward M2
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

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

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

Publication citations

Additional files

Editorial Notes