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
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