Prostate CancerKOALANCT02588846
Multi-target Tracking in Prostate Radiotherapy Using MLC and KIM
A study testing Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' in people with Prostate Cancer, run by Royal North Shore Hospital at 1 site in Australia.
Trial summary
Assessing the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to account for the relative motion of the moving prostate tumour target and the static pelvic nodal target for high-risk prostate cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Oct 2024to 3 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing definitive external beam radiotherapy at Northern Sydney Cancer Centre
- Patients histologically proven prostate adenocarcinoma
- PSA obtained within 3 months prior to enrolment
- Pelvic lymph nodes are included for treatment for patients at stage T1c-T3b with Gleason 8-10 or prostate-specific antigen (PSA) > 20 ng/ml or pelvic lymph node positivity on conventional imaging or prostate-specific membrane antigen (PSMA) scans.
- Patient must be able to have gold fiducial markers placed in the prostate
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Ability to understand and the willingness to sign a written informed consent document.
- Prostate dimension that allows leaf span with tracking margin of ±8mm
Who cannot join
- Patients with artificial Hip(s), lumbar spinal surgical rods or other large metallic pelvic implants
- Patient's dimensions >40cm as measured at the level of the prostate
- Patients with overlapping implanted gold fiducials in x-ray imaging
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
Official title: Phase I Feasibility Study of Accounting for Relative Motion of Multiple Targets in Prostate Cancer Radiotherapy Using Realtime Multi-leaf Collimator Adaptation and Kilovoltage (kV) Intrafraction Monitoring
Assessing the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to account for the relative motion of the moving prostate tumour target and the static pelvic nodal target for high-risk prostate cancer patients. The capability of tracking for the relative motion of multiple targets will ensure that all the treatment targets receive correct dose as prescribed by the doctor and minimise side effects to the critical organs.
Read the detailed description
This study will assess the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to account for the relative motion of the moving prostate tumour target and the static pelvic nodal target for high-risk prostate cancer patients. The capability of tracking for the relative motion of multiple targets will ensure that all the treatment targets receive correct dose as prescribed by the doctor and minimising side effects to the critical organs.
During radiation treatment, the prostate position will be monitored in real time using the KIM technology. The nodal target will be imaged before and after each treatment to evaluate the nodal treatment margin. The MLC tracking is implemented by recalculating the radiation beam shape fit for the moved prostate and static nodal targets and sending the adjusted MLC leaf positions to the treatment delivery system. The actually delivered dose to the patient will be calculated after the treatment and compared to the dose without MLC tracking to assess the treatment efficacy.
- Conditions
- Prostate Cancer
- Being tested
- Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'
- Keywords
- Prostate, Radiotherapy, IGRT, VMAT, Image-guided radiation therapy, Volumetric modulated arc therapy, Adaptive radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'Device
Also called MLC, KIM
This intervention uses the simultaneous combined use of two technologies: 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'. kV Intrafraction Monitoring (KIM) measures the motion of tissues targeted for radiotherapy in real time using kV imaging.The multi-leaf collimator (MLC) reshapes the radiation beam to maximise dose to the target tissue and minimise dose to the surrounding healthy tissue. Combining KIM and MLC allows the shaped radiation beam to follow the moving target (the prostate) while remaining fixed on a stationary target (lymph nodes) that are also being treated at the same time.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Optimise nodal treatment margin | Experimental | During Stage 1: Optimise nodal treatment margin, Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' will be used to reshape the radiation beam in real-time. The nodal target position stability will be evaluated by the cone beam computed tomography (CBCT) imaging before and after each treatment session for the first 10 patients. Receives: Device: Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' |
| Stage 2: Use treatment margin | Experimental | During Stage 2: Use treatment margin, Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' will be used to reshape the radiation beam in real-time. At the same time, multi-leaf collimator (MLC) tracking will be used to reshape the radiation beam in real-time using the margin size determined in Stage 1. Receives: Device: Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Software or mechanical failure
The percentage of fractions delivered without software or mechanical failure
Measured: The treatment period (2-9 weeks)
Secondary outcomes (4)
Geometric accuracy
The geometric accuracy of the beam shape, determined by comparing the ideal beam shape with the actual beam shape.
Measured: The treatment period (2-9 weeks)
Prostate motion trajectory
Prostate motion trajectory measured by KIM.
Measured: Treatment period (2-9 weeks)
Dosimetric accuracy
The estimated dose distributions will be compared to the original plan using the dose reconstruction method18 based on the prostate motion trajectory and the logged MLC positions (beam shapes).
Measured: Treatment period (2-9 weeks)
Acute toxicity
Toxicity during treatment
Measured: Treatment period (2-9 weeks) plus 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start3 Oct 2024
- Primary completion3 Oct 2024
- Study completion3 Oct 2024
Why it stopped: no resources to run the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All patients receive the intervention for comparison against retrospective matched cohort.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Thomas Eade, Royal North Shore Hospital
- Investigators
- Thomas Eade, MBBS, RANZCR, Principal investigator, Director of Research, Senior Staff Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588846
- Sponsor's protocol ID
- Multi-target tracking
- Acronym
- KOALA
- Status last verified
- Nov 2024
- First submitted
- 14 Jul 2015
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share for research purposes with interested parties.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Feasibility Study of Accounting for Relative Motion of Multiple Targets in Prostate Cancer Radiotherapy Using Realtime Multi-leaf Collimator Adaptation and Kilovoltage (kV) Intrafraction Monitoring
- ClinicalTrials.gov ID
- NCT02588846
- Acronym / sponsor ID
- KOALA / Multi-target tracking
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Radiotherapy, IGRT, VMAT, Image-guided radiation therapy, Volumetric modulated arc therapy, Adaptive radiotherapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no resources to run the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 3 Oct 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessing the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to account for the relative motion of the moving prostate tumour target and the static pelvic nodal target for high-risk prostate cancer patients. The capability of tracking for the relative motion of multiple targets will ensure that all the treatment targets receive correct dose as prescribed by the doctor and minimise side effects to the critical organs.
Detailed description
This study will assess the feasibility of implementing real-time multi-leaf collimator (MLC) tracking to account for the relative motion of the moving prostate tumour target and the static pelvic nodal target for high-risk prostate cancer patients. The capability of tracking for the relative motion of multiple targets will ensure that all the treatment targets receive correct dose as prescribed by the doctor and minimising side effects to the critical organs.
During radiation treatment, the prostate position will be monitored in real time using the KIM technology. The nodal target will be imaged before and after each treatment to evaluate the nodal treatment margin. The MLC tracking is implemented by recalculating the radiation beam shape fit for the moved prostate and static nodal targets and sending the adjusted MLC leaf positions to the treatment delivery system. The actually delivered dose to the patient will be calculated after the treatment and compared to the dose without MLC tracking to assess the treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients receive the intervention for comparison against retrospective matched cohort.
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Optimise nodal treatment margin | Experimental | Device: Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'During Stage 1: Optimise nodal treatment margin, Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' will be used to reshape the radiation beam in real-time. The nodal target position stability will be evaluated by the cone beam computed tomography (CBCT) imaging before and after each treatment session for the first 10 patients. |
| Stage 2: Use treatment margin | Experimental | Device: Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'During Stage 2: Use treatment margin, Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' will be used to reshape the radiation beam in real-time. At the same time, multi-leaf collimator (MLC) tracking will be used to reshape the radiation beam in real-time using the margin size determined in Stage 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients undergoing definitive external beam radiotherapy at Northern Sydney Cancer Centre
- Patients histologically proven prostate adenocarcinoma
- PSA obtained within 3 months prior to enrolment
- Pelvic lymph nodes are included for treatment for patients at stage T1c-T3b with Gleason 8-10 or prostate-specific antigen (PSA) > 20 ng/ml or pelvic lymph node positivity on conventional imaging or prostate-specific membrane antigen (PSMA) scans.
- Patient must be able to have gold fiducial markers placed in the prostate
Key exclusion criteria (3 listed)
- Patients with artificial Hip(s), lumbar spinal surgical rods or other large metallic pelvic implants
- Patient's dimensions >40cm as measured at the level of the prostate
- Patients with overlapping implanted gold fiducials in x-ray imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'Also: MLC, KIMThis intervention uses the simultaneous combined use of two technologies: 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'. kV Intrafraction Monitoring (KIM) measures the motion of tissues targeted for radiotherapy in real time using kV imaging.The multi-leaf collimator (MLC) reshapes the radiation beam to maximise dose to the target tissue and minimise dose to the surrounding healthy tissue. Combining KIM and MLC allows the shaped radiation beam to follow the moving target (the prostate) while remaining fixed on a stationary target (lymph nodes) that are also being treated at the same time. | Device | Stage 1: Optimise nodal treatment margin, Stage 2: Use treatment margin |
Primary outcome
Software or mechanical failure
Time frame: The treatment period (2-9 weeks)
The percentage of fractions delivered without software or mechanical failure
4 secondary outcomes
Geometric accuracy
Time frame: The treatment period (2-9 weeks)
Prostate motion trajectory
Time frame: Treatment period (2-9 weeks)
Dosimetric accuracy
Time frame: Treatment period (2-9 weeks)
Acute toxicity
Time frame: Treatment period (2-9 weeks) plus 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Yes. Share for research purposes with interested parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Eade, MBBS, RANZCR principal investigator
Director of Research, Senior Staff Specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' in people with Prostate Cancer, run by Royal North Shore Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Software or mechanical failure (time frame: The treatment period (2-9 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.