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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01742403




Registration number
NCT01742403
Ethics application status
Date submitted
2/12/2012
Date registered
5/12/2012

Titles & IDs
Public title
Continuous Monitoring of Prostate Position During Radiotherapy
Scientific title
Phase I Feasibility Study of Prostate Cancer Radiotherapy Gating Using kV Intrafraction Monitoring (KIM)
Secondary ID [1] 0 0
12-NSCCRO-P001
Universal Trial Number (UTN)
Trial acronym
KIM Gating
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 - R/T gating kV intrafraction monitoring

Experimental: R/T gating kV intrafraction monitoring - Intervention: Recruitment will be performed in 2 phases:

Phase I will include the first 10 patients. All patients will be treated on a standard fractionation protocol with 40 fractions. This will allow 400 potential fractions to be auto-segmented in real time. Once Phase I is successfully completed we will aim to continue recruitment of a further 20 patients as Phase II. For this phase we will open recruitment to patients with lymph node positivity, hypofractionation (as per Department protocols) and intermittent imaging (imaging less frequently than every fraction).


Treatment: Other: R/T gating kV intrafraction monitoring
This is a Phase I Pilot study to assess the feasibility of implementing prostate radiotherapy gating using kV intrafraction monitoring.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of KIM techique
Timepoint [1] 0 0
10 years
Secondary outcome [1] 0 0
Time for procedure
Timepoint [1] 0 0
10 years

Eligibility
Key inclusion criteria
* Patients undergoing definitive external beam radiotherapy;
* Histological proven prostate adenocarcinoma
* Prostate Specific Antigen (PSA),within 3 months prior to enrolment
* Patient must be able to have gold fiducial markers placed in the prostate (if on anticoagulants, must be approved for procedure by Cardiologist)
* Artificial hips
* Lymph Node irradiation
* Patient Dimensions >40cms
* ECOG 0-2
* Ability to understand and willingness to sign informed consent form.
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Altered fractionation
* Fiducials must be no less than 1cm apart

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Department of Radiation Oncology, Northern Sydney Cancer Centre - St. Leonards
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas 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
Thomas N Eade, MBBS
Address 0 0
Country 0 0
Phone 0 0
+61294631319
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
With other ethics approved centres using annonymised data.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT01742403