Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
15/04/2016
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

Dr Isabel Syndikus

ORCID ID

Contact details

Clatterbridge Centre for Oncology
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom
+44 (0)151 334 1155
isabel.syndikus@ccotrust.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0067124367

Study information

Scientific title

Gold seed markers for improved set-up accuracy during high dose radiotherapy for prostate cancer

Acronym

Study hypothesis

To assess the impact on set-up accuracy of 4 methods of preparing the patient's bladder and rectum before radiotherapy, using gold seed markers for reference

Ethics approval

Granted by Wirral Local Research Ethics Committee (UK) on 16/04/2003, reference number 33/03.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cancer: Prostate

Intervention

1. Clinical trial
2. Randomised trial
2.1 Full bladder, empty rectum
2.2 Full bladder, full rectum
2.3 Empty bladder, empty rectum
2.4 Empty bladder, full rectum

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Prior to July 2008:
1. Prostate position and movement
2. Radiation dose to tumour and normal tissues
3. Toxicity
4. Quality of life
5. Biochemical relapse free survival
6. Overall survival

Modified on 23 July 2008 - primary end points as follows:
1. Determination of magnitude of set-up errors in radiotherapy of prostate cancer using current and alternative set-up procedures
2. Early and late treatment toxicity
3. Biochemical (PSA) relapse free survival
4. Overall survival will also be recorded, but the study is not large enough to detect any difference between the groups

Secondary outcome measures

Not provided at time of registration

Overall trial start date

21/05/2003

Overall trial end date

11/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with prostate cancer undergoing radiotherapy.

Added 29 July 2008:
1. Histologically confirmed, previously untreated, locally confined adenocarcinoma of the prostate (T1-T3a, NO, MO)
2. PSA <50NG/ML prior t any hormone therapy
3. No other malignancy within the previous 5 years
4. No indwelling urinary catheter
5. The use of neoadjuvant hormone therapy is permitted, but not mandatory

Participant type

Patient

Age group

Not Specified

Gender

Male

Target number of participants

Total target recruitment = 48 patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

21/05/2003

Recruitment end date

11/11/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clatterbridge Centre for Oncology
Wirral
CH63 4JY
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

Clatterbridge Centre for Oncology 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

15/04/2016: No publications found, verifying study status with principal investigator.