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Clinical Trials/NCT02588846
NCT02588846WithdrawnNot Applicable

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

Royal North Shore Hospital2 sites in 1 countryStarted: October 3, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
2
Primary Endpoint
Software or mechanical failure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Software or mechanical failure

Time Frame: The treatment period (2-9 weeks)

The percentage of fractions delivered without software or mechanical failure

Secondary Outcomes

  • Dosimetric accuracy(Treatment period (2-9 weeks))
  • Geometric accuracy(The treatment period (2-9 weeks))
  • Prostate motion trajectory(Treatment period (2-9 weeks))
  • Acute toxicity(Treatment period (2-9 weeks) plus 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Professor Thomas Eade

Head of Research

Royal North Shore Hospital

Study Sites (2)

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