| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN05909154 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0067189218 |
| Public title | SEED 02 - Evaluation of Image Guided Radiotherapy Techniques for Prostate Radiotherapy |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer: Prostate |
| Study hypothesis | To compare different ways of taking images of the prostate and its position during radiotherapy treatment (high energy x-rays beams). Daily 'on line' kilo voltage imaging will be compared to 'off-line mega voltage imaging' and a standard imaging protocol. This is known as Image Guided Radiotherapy or IGRT. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histological confirmed, previously untreated, locally confined adenocarcinoma of the prostate (T1-T3a, N0, M0)
2. PSA <50ng/ml prior to any hormone therapy
3. Suitable and fit for radical conformal therapy or intensity-modulated radiotherapy |
| Participants - exclusion criteria | 1. Other stages of prostate cancer than T1-T3a, N0, M0 as these may indicate different treatment
2. Patients not suitable for radiotherapy
3. Other malignancy within the previous 5 years (as they may have had treatment that will interfere with this study)
4. Indwelling urinary catheter
5. No total hip replacement (as this affects the imaging scanner). |
| Patient information material |
|
| Anticipated start date | 11/08/2006 |
| Anticipated end date | 31/08/2008 |
| Status of trial | Ongoing |
| Target number of participants | 48, 24 in each arm |
| Interventions | Patients will have small gold seeds implanted into the prostate under local anaesthetic. Radiotherapy treatment planned as normal then randomised to be imaged by either:
1. Retrospective 'off-line' mega voltage imaging (standard technique)
2. Daily 'on line' kilo voltage imaging (newer technique)
for the 7- 8 weeks of radiotherapy. In both arms, the seed markers are used for treatment verification.
Additionally patients undergo a cone beam CT weekly prior to treatment. One follow-up visit approximately 1 month after completion of radiotherapy, then normal follow-up.
The study will assess the current verification methods available (Daily 'on line' kilovolt age imaging, 'off-line' mega voltage cancer) The different technologies will be directly compared in this randomised controlled trial. All eligible patients will be consented, and will then have small gold seeds implanted into the prostate under local anaesthetic. Approximately 2-3 weeks later they will attend the radiotherapy centre and have their treatment planned as normal. This involves having scans taken and having small tattoos marked on their skin. After the CT planning scan, patients will be randomised to be imaged by either:
A: Retrospective 'off-line' mega voltage imaging (standard technique)
B: Daily 'on line' kilovolt age imaging (newer technique) during the 7-8 weeks of their radiotherapy
During treatment, the patient is positioned on the treatment couch as per standard protocol. In both arms, the seed markers are used for treatment verification. The mega voltage imaging is performed according to the standard imaging protocol. Other images, known as orthogonal EPID images of the treatment fields (the area being treated) are taken daily. These images will only be used later to compare daily variation in seed position. Kilovolt age images are taken every day prior to treatment and the patient will be repositioned as needed daily as per standard protocol. After the correction and directly before the treatment commences, mega voltage images of each field are recorded in the same way as in the other arm. Additionally patients undergo a cone beam CT weekly prior to the treatment. |
| Primary outcome measure(s) | Mean total displacement in tumour bed centre of gravity during a course of radiotherapy in both treatment arms |
| Secondary outcome measure(s) | 1. Mean daily displacement in tumour bed centre of gravity expressed as 3D co-ordinates
2. Intra- and inter-observer variability in marker localisation
3. Tolerance level of positional correction
4. Production of an on line image correction protocol |
| Sources of funding | Clatterbridge Centre for Oncology NHS Trust
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Isabel Syndikus |
| Contact details | Clatterbridge Centre for Oncology
Clatterbridge Road
Bebington
Wirral
Merseyside
United Kingdom
CH63 4JY |
| Contact telephone | +44 0151 334 1155 |
| Contact fax | +44 0151 482 7675 |
| Contact email | isabel.syndikus@ccotrust.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN05909154 |
| Date last extracted from ISRCTN register | 17/04/2008 |
