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

ISRCTN	ISRCTN76286772
DOI	https://doi.org/10.1186/ISRCTN76286772
Secondary identifying numbers	N0067124367

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 15/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Isabel Syndikus
Scientific

Clatterbridge Centre for Oncology
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom

Phone	+44 (0)151 334 1155
Email	isabel.syndikus@ccotrust.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Gold seed markers for improved set-up accuracy during high dose radiotherapy for prostate cancer
Study objectives	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(s)	Granted by Wirral Local Research Ethics Committee (UK) on 16/04/2003, reference number 33/03.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	21/05/2003
Completion date	11/11/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target number of participants	Total target recruitment = 48 patients
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	21/05/2003
Date of final enrolment	11/11/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clatterbridge Centre for Oncology

Wirral
CH63 4JY
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

Clatterbridge Centre for Oncology NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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