- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05481372
PINPOINT Feasibility Study
Pioneering Imaging Techniques for Optimising Dose Delivery in Post-Operative Prostate Radiotherapy. A Feasibility Study.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sophie Alexander
- Phone Number: 020 8915 6053
- Email: sophie.alexander@rmh.nhs.uk
Study Locations
-
-
Gastrointestinal (lower)
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Sutton, Gastrointestinal (lower), United Kingdom, kt5 8hx
- Recruiting
- Sophie Alexander
-
Contact:
- Sophie Alexander
- Phone Number: 020 8915 6053
- Email: sophie.alexander@rmh.nhs.uk
-
Contact:
- Julia Murray
- Email: julia.murray@icr.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Trans-perineal ultrasound and Magnetic resonance image acquisition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reliability of anatomical structure visualisation
Time Frame: 14 months
|
Reliability of anatomical structure visualisation determined by mean dice similarity coefficient (DSC) and mean surface-to-surface distance (MSSD) for delineated structures (urethra, bladder neck, VUA, retrovesicle space, penile bulb, pubic symphysis and rectum) on MRI, CT, TPUS and CBCT across observers.
If DSC is ≥ 0.75 the structure is deemed to be reliably visible.
|
14 months
|
Frequency of anatomical structure visualisation
Time Frame: 14 months
|
Frequency of anatomical structure visualisation by average user rating of urethra, bladder neck, VUA, retrovesicle space, penile bulb, public symphysis and anterior rectal wall visualisation on MRI, CT, TPUS, CBCT and fused multimodality imaging (CT, MRI, TPUS).
|
14 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anatomical structure motion
Time Frame: 14 months
|
On TPUS, the distance (mm) between anterior rectal wall and posterior pubic symphysis measured every 30 seconds over 10 minutes and the distance (mm) between VUA and superior aspect of penile bulb measured every 30 seconds over 10 minutes.
|
14 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR 5380
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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