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Trial Title:
PINPOINT Feasibility Study
NCT ID:
NCT05481372
Condition:
Prostate Cancer
Image Guided Radiotherapy
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single centre feasibility study
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Imaging
Description:
Trans-perineal ultrasound and Magnetic resonance image acquisition
Arm group label:
Standard radiotherapy with research image acquisition
Summary:
This feasibility study is investigating the application of magnetic resonance imaging
(MRI) and transperineal ultrasound (TPUS) to visualise potential sites of relapse and
surrounding normal tissue in patient having post-operative prostate cancer radiotherapy.
Structure visualisation on MRI and TPUS will be compared to current standard computer
tomography (CT) and cone-beam computer tomography (CBCT) imaging.
Detailed description:
Approximately 47,000 men are diagnosed with prostate cancer yearly in the UK, 15% of
which receive surgery (radical prostatectomy) as primary treatment. Of these men one
third develop recurrence after prostatectomy and are offered post-operative radiotherapy.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient has undergone radical prostatectomy
- 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:
- Recruitment into POPS trial
- Contraindications to MRI such as having a pacemaker or non-MRI compatible implanted
device
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sophie Alexander
Address:
City:
Sutton
Zip:
kt5 8hx
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Sophie Alexander
Phone:
020 8915 6053
Email:
sophie.alexander@rmh.nhs.uk
Contact backup:
Last name:
Julia Murray
Email:
julia.murray@icr.ac.uk
Start date:
August 2022
Completion date:
December 2023
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Source:
Royal Marsden NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05481372