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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02397317




Registration number
NCT02397317
Ethics application status
Date submitted
9/03/2015
Date registered
24/03/2015

Titles & IDs
Public title
Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction Monitoring
Scientific title
Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction
Secondary ID [1] 0 0
TROG 15.01
Secondary ID [2] 0 0
TROG 15.01 SPARK
Universal Trial Number (UTN)
Trial acronym
SPARK
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 - Multi-fraction SABR

Experimental: Multi-fraction SABR - All participants will receive Multi-Fraction SABR; 36.25 Gy (PTV D95) in 5 Fractions within 2-5 weeks


Treatment: Other: Multi-fraction SABR
All participants will receive Multi-Fraction SABR; 36.25 Gy (PTV D95) in 5 Fractions within 2-5 weeks
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Accumulated patient dose distributions will be determined via paired controls by comparing the measured treatment accuracy and dose with KIM and those that would have been delivered in the absence of KIM
Timepoint [1] 0 0
up to 36 months
Secondary outcome [1] 0 0
Patient treatment outcomes determined by assessing Biochemical-clinical failure (BCF)
Timepoint [1] 0 0
up to a maximum of 36 months.
Secondary outcome [2] 0 0
Patient treatment outcomes determined by assessing acute and late toxicity grade 3 or higher (using CTCAE version 4)
Timepoint [2] 0 0
Weekly during treatment, then two weeks, six weeks and 6 months post treatment
Secondary outcome [3] 0 0
Patient treatment outcomes determined by assessing patient-reported outcomes
Timepoint [3] 0 0
12 and 24 months after treatment
Secondary outcome [4] 0 0
The patient's perception of KIM will be quantified using an adapted SAT-RAR survey, an instrument that has previously been used to assess patient perceptions on technological innovations in radiotherapy and respiratory gating.
Timepoint [4] 0 0
up to 36 months
Secondary outcome [5] 0 0
Targeting accuracy through measuring the final geometric accuracy with and without the KIM gating procedure
Timepoint [5] 0 0
up to 36 months
Secondary outcome [6] 0 0
Radiation therapists feedback on KIM will be quantified using a survey which will obtain specific information about the impact of the KIM system and SPARK on education, patient workflow, clinical impact and user confidence
Timepoint [6] 0 0
up to 36 months

Eligibility
Key inclusion criteria
1. Histologically proven prostate adenocarcinoma
2. Low or intermediate risk disease as defined by:

* Low Risk: All of PSA<10 ng/mL, Gleason Grade 6 AND Stage T1 or T2a
* Intermediate Risk: Any or all of PSA 10-20 ng/mL, Gleason Grade 7 OR Stage T2b-c
* Absence of high risk features (PSA>20, T3-4, N1 or M1 disease, Gleason score 8-10) (PSA must be within 3 months prior to enrolment)
3. ECOG Performance status 0-2
4. Suitable for definitive external beam radiotherapy (IMRT or VMAT)
5. Ability to have three gold fiducial markers placed in the prostate
6. Six month course of androgen deprivation therapy allowed at clinician discretion.
7. Available for follow up for a minimum of 2 years (up to 3 years)
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lymph node irradiation
2. Any other systemic anti-prostate cancer therapy (i.e. non-ADT) both proven in the metastatic setting and investigational (e.g. docetaxel, enzalutamide)
3. Artificial hip(s) (Unable to visualise markers through prosthesis)
4. Prostate volume > 90 cm3 measured from the CT scan
5. Patient lateral dimension >40cm as measured at the level of the prostate from the CT scan
6. Suboptimal fiducial markers placement for treatment utilising KIM as assessed by a medical physicist by measuring marker positions from the CT scan
7. Fiducial migration or fewer than 3 fiducials present in the CT scan

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
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [2] 0 0
Liverpool Cancer Therapy Centre - Sydney
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
The Crown Princess Mary Cancer Centre Westmead - Sydney
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2298 - Newcastle
Recruitment postcode(s) [2] 0 0
1871 - Sydney
Recruitment postcode(s) [3] 0 0
2065 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Sydney
Recruitment postcode(s) [5] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Trans Tasman Radiation Oncology Group
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
Paul Keall
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul Keall
Address 0 0
Country 0 0
Phone 0 0
+61 2 9351 3590
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)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02397317