Multi-target Tracking in Prostate Radiotherapy Using MLC and KIM

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02588846
• Other study ID #: Multi-target tracking
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Royal North Shore Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'
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.

Locations

Country	Name	City	State
Australia	Royal North Shore Hospital	St Leonards	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Royal North Shore Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Software or mechanical failure	The percentage of fractions delivered without software or mechanical failure	The treatment period (2-9 weeks)
Secondary	Geometric accuracy	The geometric accuracy of the beam shape, determined by comparing the ideal beam shape with the actual beam shape.	The treatment period (2-9 weeks)
Secondary	Prostate motion trajectory	Prostate motion trajectory measured by KIM.	Treatment period (2-9 weeks)
Secondary	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).	Treatment period (2-9 weeks)
Secondary	Acute toxicity	Toxicity during treatment	Treatment period (2-9 weeks) plus 3 months