NCT02033343

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

4.3 years

First QC Date

January 9, 2014

Last Update Submit

June 10, 2021

Conditions

Prostate Cancer

Keywords

Prostate CancerReal-time trackingRadiotherapyDynamic Multileaf Collimator

Outcome Measures

Primary Outcomes (1)

  • Percentage of fractions being successfully delivered with Calypso-guided tracking.

    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 Outcomes (5)

  • Improvement in overall beam-target geometric alignment.

    2 years

  • Improvement in dosimetric coverage of prostate and normal healthy structures.

    2 years

  • Acute toxicity

    Assessed up to 12 weeks post treatment

  • Late toxicity

    Up to five years

  • Biochemical control

    Up to five years

Study Arms (1)

Real-time tracking & beam adjustment

EXPERIMENTAL

Prostate cancer radiotherapy using real-time tracking

Radiation: Prostate cancer radiotherapy using real-time tracking

Interventions

Prostate cancer radiotherapy using real-time trackingRADIATION

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

Real-time tracking & beam adjustment

Eligibility Criteria

Age35 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Sydney Cancer Centre, Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Related Publications (3)

  • Colvill E, Booth JT, O'Brien RT, Eade TN, Kneebone AB, Poulsen PR, Keall PJ. Multileaf Collimator Tracking Improves Dose Delivery for Prostate Cancer Radiation Therapy: Results of the First Clinical Trial. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):1141-1147. doi: 10.1016/j.ijrobp.2015.04.024. Epub 2015 Apr 17.

    PMID: 26194684BACKGROUND

  • Keall PJ, Colvill E, O'Brien R, Ng JA, Poulsen PR, Eade T, Kneebone A, Booth JT. The first clinical implementation of electromagnetic transponder-guided MLC tracking. Med Phys. 2014 Feb;41(2):020702. doi: 10.1118/1.4862509.

    PMID: 24506591RESULT

  • Colvill E, Poulsen PR, Booth JT, O'Brien RT, Ng JA, Keall PJ. DMLC tracking and gating can improve dose coverage for prostate VMAT. Med Phys. 2014 Sep;41(9):091705. doi: 10.1118/1.4892605.

    PMID: 25186380RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Thomas N Eade, MBBS

    Royal North Shore Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 10, 2014

Study Start

October 1, 2013

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations

AU(1)