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Multi-target Tracking in Prostate Radiotherapy Using MLC and KIM (KOALA)

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'
Sponsored by
Royal North Shore Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, Radiotherapy, IGRT, VMAT, Image-guided radiation therapy, Volumetric modulated arc therapy, Adaptive radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Royal North Shore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stage 1: Optimise nodal treatment margin

Stage 2: Use treatment margin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Software or mechanical failure
The percentage of fractions delivered without software or mechanical failure

Secondary Outcome Measures

Geometric accuracy
The geometric accuracy of the beam shape, determined by comparing the ideal beam shape with the actual beam shape.
Prostate motion trajectory
Prostate motion trajectory measured by KIM.
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).
Acute toxicity
Toxicity during treatment

Full Information

First Posted
July 14, 2015
Last Updated
October 25, 2022
Sponsor
Royal North Shore Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02588846
Brief Title
Multi-target Tracking in Prostate Radiotherapy Using MLC and KIM
Acronym
KOALA
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Abandoned. No resources
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal North Shore Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, Radiotherapy, IGRT, VMAT, Image-guided radiation therapy, Volumetric modulated arc therapy, Adaptive radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients receive the intervention for comparison against retrospective matched cohort.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1: Optimise nodal treatment margin
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 2: Use treatment margin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'
Other Intervention Name(s)
MLC, KIM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Software or mechanical failure
Description
The percentage of fractions delivered without software or mechanical failure
Time Frame
The treatment period (2-9 weeks)
Secondary Outcome Measure Information:
Title
Geometric accuracy
Description
The geometric accuracy of the beam shape, determined by comparing the ideal beam shape with the actual beam shape.
Time Frame
The treatment period (2-9 weeks)
Title
Prostate motion trajectory
Description
Prostate motion trajectory measured by KIM.
Time Frame
Treatment period (2-9 weeks)
Title
Dosimetric accuracy
Description
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).
Time Frame
Treatment period (2-9 weeks)
Title
Acute toxicity
Description
Toxicity during treatment
Time Frame
Treatment period (2-9 weeks) plus 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Eade, MBBS, RANZCR
Organizational Affiliation
Director of Research, Senior Staff Specialist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Share for research purposes with interested parties.

Learn more about this trial

Multi-target Tracking in Prostate Radiotherapy Using MLC and KIM

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