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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hypofractionated Stereotactic Body Radiation Therapy (SBRT)

NCT01288534

Prostate Cancer

COMPLETED PHASE2

Multi-target Tracking in Prostate Radiotherapy Using MLC and KIM

NCT02588846

Prostate Cancer

WITHDRAWN NA

Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking

NCT02514512

Neoplasms Lung Neoplasms

ACTIVE_NOT_RECRUITING NA

Early Investigation of High Precision Radiotherapy Prior to Commencing Standard Radiotherapy for Prostate Cancer

NCT02004223

Prostate Cancer

COMPLETED NA

Measuring the Effect of Radiation Therapy on Patient Activity Levels

NCT02694380

Head and Neck Cancer Prostate Cancer Breast Cancer +1 more

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Real-time tracking & beam adjustment

Prostate cancer radiotherapy using real-time tracking

Group Type EXPERIMENTAL

Prostate cancer radiotherapy using real-time tracking

Intervention Type RADIATION

Radiotherapy delivered using Calypso radiofrequency emitting beacon guided real-time prostate localisation and beam adjustment using Dynamic Multi-leaf Collimator tracking software.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No