Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02033343




Registration number
NCT02033343
Ethics application status
Date submitted
9/01/2014
Date registered
10/01/2014
Date last updated
14/06/2021

Titles & IDs
Public title
Feasibility Study Into Adjustment of the Radiation Beam to Account for Prostate Motion During Radiotherapy.
Scientific title
Phase I Feasibility Study of Prostate Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator Adaptation and Radiofrequency Tracking (Calypso)
Secondary ID [1] 0 0
12-NSCCRO-P002
Universal Trial Number (UTN)
Trial acronym
CALYPSO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Prostate cancer radiotherapy using real-time tracking

Experimental: Real-time tracking & beam adjustment - Prostate cancer radiotherapy using real-time tracking


Treatment: Other: 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 code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of fractions being successfully delivered with Calypso-guided tracking.
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Improvement in overall beam-target geometric alignment.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Improvement in dosimetric coverage of prostate and normal healthy structures.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Acute toxicity
Timepoint [3] 0 0
Assessed up to 12 weeks post treatment
Secondary outcome [4] 0 0
Late toxicity
Timepoint [4] 0 0
Up to five years
Secondary outcome [5] 0 0
Biochemical control
Timepoint [5] 0 0
Up to five years

Eligibility
Key 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
Minimum age
35 Years
Maximum age
85 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2018
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Northern Sydney Cancer Centre, Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02033343
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Thomas N Eade, MBBS
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02033343