Feasibility Study Into Adjustment of the Radiation Beam to Account for Prostate Motion During Radiotherapy. (CALYPSO)

June 10, 2021 updated by: Professor Thomas Eade, Royal North Shore Hospital

Phase I Feasibility Study of Prostate Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator Adaptation and Radiofrequency Tracking (Calypso)

The purpose of this study is to monitor movement of the prostate during radiotherapy and adjust the radiation beam to account for any motion seen. This will increase the radiation dose to the prostate and decrease the dose to the rectum and bladder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prostate cancer now accounts for one third of all new cancer diagnoses in men and approximately 30% of men will have external beam radiotherapy as their primary local therapy. Prostate motion during radiotherapy can be divided into interfraction and intrafraction motion. Interfraction motion has been well established and has been largely overcome by daily online image verification with either ultrasound, online CT or implanted fiducial markers, however motion during the radiation beam on time (intrafraction motion) is not corrected and can be the cause of significant errors in radiation dose delivery.

The most common technology utilised in 2012 to allow prostate gating is the Calypso system. The Calypso system consists of implantable electromagnetic transponders, an array that contains source and receiver coils, computers for data analysis and display purposes, and an infrared camera system to localise the electromagnetic array in the treatment room. The array is placed over the patient, and the source coil in the array emit an electromagnetic signal that excites the transponders. Once the transponders are excited, the source coils are turned off and the receiver coils detect the signal emitted from the excited transponders. This process is repeated at a rate of 10 Hz, providing a realtime radiofrequency localisation of the prostate triangulating three implanted beacons. The current study will investigate using the continuous prostate positioning data from Calypso to integrate with the treatment beam delivery and allow real-time adaptation based on the prostate motion. This is called Realtime Dynamic Multileaf Collimator (DMLC) tracking. In this technique the multileaf collimator motion is altered in the gantry head in real time during beam delivery to account for the measured prostate motion.

The proposed study is examining the dosimetric impact of accounting for intrafraction motion with Calypso and DMLC tracking. We hypothesise the improvements in delivered prostate dose with DMLC tracking will be even greater than gating. This improved treatment delivery will ensure that the prostate cancer receives the appropriate dose and that normal tissues are spared from extra radiation.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Northern Sydney Cancer Centre, Royal North Shore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients undergoing external beam radiotherapy at Northern Sydney Cancer Centre
  • Histologically proven prostate adenocarcinoma
  • Prostate Specific Antigen (PSA) obtained within 3 months prior to enrolment.
  • Patient must be able to have Varian Calypso beacons placed in the prostate (if on anticoagulants, must be cleared by Local Medical Officer or cardiologist).
  • ECOG performance status 0-2
  • Ability to understand and the willingness to sign a written informed consent document.
  • Body habitus enabling Calypso tracking (as per Calypso Determining a Patient's Localisation Designation & Orientation before implantation)
  • Prostate dimension that allows leaf span with tracking margin of ±8mm

Exclusion Criteria:

  • Previous pelvic radiotherapy
  • Prior total prostatectomy
  • Pacemaker
  • Implantable defibrillator
  • Insulin infusion pump
  • Hip prosthesis
  • Unwilling or unable to give informed consent
  • Unwilling or unable to complete quality of life questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Real-time tracking & beam adjustment
Prostate cancer radiotherapy using real-time tracking
Radiation: Prostate cancer radiotherapy using real-time tracking
Radiotherapy delivered using Calypso radiofrequency emitting beacon guided real-time prostate localisation and beam adjustment using Dynamic Multi-leaf Collimator tracking software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of fractions being successfully delivered with Calypso-guided tracking.
Time Frame: 2 years
The primary endpoint of this Pilot study is to evaluate the feasibility of implementing realtime adaptive radiotherapy using DMLC. This will be assessed as greater than 95% of fractions being successfully delivered (no equipment failures and tracking MLC follows beacons) with Calypso-guided tracking.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in overall beam-target geometric alignment.
Time Frame: 2 years
Geometric alignment will be measured as average difference between beacon centroid and shifted MLC against original MLC.
2 years
Improvement in dosimetric coverage of prostate and normal healthy structures.
Time Frame: 2 years
Dosimetric improvement will be assessed by applying the methods of Poulsen to reconstruct delivered dose distributions for each fraction of patient cohort and summed total dose. Preliminary data demonstrates dose reconstruction to follow the planned dose distribution, potentially even for ultrahypofractionated cases with longer treatment duration and Flattening Filter Free (FFF) delivery with larger potential delivery error per time increment.
2 years
Acute toxicity
Time Frame: Assessed up to 12 weeks post treatment
Portion of patients with grade 3 or greater genitourinary or gastrointestinal toxicity assessed using the Modified Radiation Therapy Oncology Group (RTOG) Toxicity Scale.
Assessed up to 12 weeks post treatment
Late toxicity
Time Frame: Up to five years
Ongoing reporting of gastrointestinal and genitourinary toxicity of the DMLC tracking cohort will be compared to matched pair controls using the modified RTOG scale.
Up to five years
Biochemical control
Time Frame: Up to five years
Ongoing biochemical control of the DMLC tracking cohort will be compared to matched pair controls using Prostate Specific Antigen (PSA).
Up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal North Shore Hospital

Collaborators

University of Sydney

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2013

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (ESTIMATE)

January 10, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 10, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-NSCCRO-P002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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