Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
14 participants
INTERVENTIONAL
2022-08-31
2023-12-31
Brief Summary
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Detailed Description
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Radiotherapy is targeted at the area where the prostate used to be, this includes potential relapse sites (PRS); vesicourethral anastomosis, bladder neck and retrovesicle space. When planning post-operative radiotherapy, the lack of a visible target means surrounding normal tissue is used to guide clinical target volume (CTV) delineation. The CTV is the area of tissue to be treated to the full radiotherapy prescription and includes PRS. Typically, the CTV is defined on a radiotherapy planning computer tomography (CT) scan.
The CTV lies adjacent to the bladder and rectum and is highly susceptible to positional changes influenced by organ filling. To identify and correct for CTV displacement during daily radiotherapy a cone-beam CT (CBCT) is acquired, this is an image similar to a CT scan but taken immediately prior to treatment delivery.
CT visualisation of PRS has been reported as inadequate, increasing the risk of missing or miss-identifying CTV structures during radiotherapy planning and delivery. To compensate for restricted visualisation on CT and CBCT an additional 1cm circumference around the CTV is treated to the prescription dose, this volume is referred to as the planning target volume (PTV). This margin reduces the risk of missing the target however its inclusion of normal tissue increases the risk of patient toxicity.
We propose that visualisation of PRS and surrounding normal tissue structures is enhanced on magnetic resonance imaging (MRI) compared to CT and on transperineal ultrasound (TPUS) compared to CBCT. This project investigates the reality of this statement by quantifying the confidence and reliability with which anatomical structures can be identified and delineated on all four image types.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Standard radiotherapy with research image acquisition
Radiotherapy delivered as per standard of care Additional trans-perineal ultrasound (TPUS) imaging at three timepoints (1 x pre-treatment and 2 x treatment). Additional magnetic resonance imaging (MRI) pre-treatment.
Imaging
Trans-perineal ultrasound and Magnetic resonance image acquisition
Interventions
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Imaging
Trans-perineal ultrasound and Magnetic resonance image acquisition
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed prostate cancer
* Patient due to receive post-operative prostate bed +/- pelvic lymph node radiotherapy
* WHO performance status 0-1
* Age ≥ 18 years
* Written informed consent
Exclusion Criteria
* Contraindications to MRI such as having a pacemaker or non-MRI compatible implanted device
18 Years
MALE
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Sophie Alexander
Sutton, Gastrointestinal (lower), United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CCR 5380
Identifier Type: -
Identifier Source: org_study_id
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