PINPOINT Feasibility Study
Pioneering Imaging Techniques for Optimising Dose Delivery in Post-Operative Prostate Radiotherapy. A Feasibility Study.
1 other identifier
interventional
14
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Aug 2022
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2022
CompletedFirst Posted
Study publicly available on registry
August 1, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 1, 2022
July 1, 2022
1.3 years
July 28, 2022
July 28, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Reliability of anatomical structure visualisation
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
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 Outcomes (1)
Anatomical structure motion
14 months
Study Arms (1)
Standard radiotherapy with research image acquisition
EXPERIMENTALRadiotherapy 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.
Interventions
Trans-perineal ultrasound and Magnetic resonance image acquisition
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Recruitment into POPS trial
- Contraindications to MRI such as having a pacemaker or non-MRI compatible implanted device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sophie Alexander
Sutton, Gastrointestinal (lower), kt5 8hx, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2022
First Posted
August 1, 2022
Study Start
August 1, 2022
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
August 1, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share