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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
NA
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT02033343