Multi-target Tracking in Prostate Radiotherapy Using MLC and KIM

NCT02588846 | Withdrawn DMC

• 1 other identifier: Multi-target tracking
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate; Radiotherapy; IGRT; VMAT; Image-guided radiation therapy; Volumetric modulated arc therapy; Adaptive radiotherapy

Outcome Measures

Primary Outcomes (1)

• Software or mechanical failure

  The percentage of fractions delivered without software or mechanical failure

  The treatment period (2-9 weeks)

Secondary Outcomes (4)

• Geometric accuracy

  The treatment period (2-9 weeks)

• Prostate motion trajectory

  Treatment period (2-9 weeks)

• Dosimetric accuracy

  Treatment period (2-9 weeks)

• Acute toxicity

  Treatment period (2-9 weeks) plus 3 months

Study Arms (2)

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.

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.

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

Interventions

Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' DEVICE

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.

Also known as: MLC, KIM

Stage 1: Optimise nodal treatment margin; Stage 2: Use treatment margin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Thomas Eade, MBBS, RANZCR

  Director of Research, Senior Staff Specialist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Model Details: All patients receive the intervention for comparison against retrospective matched cohort.

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: October 28, 2015
• Study Start: October 3, 2024
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)