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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03386045




Registration number
NCT03386045
Ethics application status
Date submitted
11/12/2017
Date registered
29/12/2017
Date last updated
11/03/2020

Titles & IDs
Public title
Optimal Prostate Study
Scientific title
Optimal Prostate Fractionation Study
Secondary ID [1] 0 0
OPTIMAL
Universal Trial Number (UTN)
Trial acronym
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 - Optimal SBRT
Treatment: Other - Optimal Booster

Active Comparator: Optimal SBRT - Participants in this group will be randomised to either SBRT ( 36 to 45 GY in 5 fractions) or standard radiotherapy (60 Gy in 20 fractions). The allocation is 2 to 1. This means that two thirds of the participants on the trial will get the SBRT (5 treatments) and one third will get the standard fractions.

Active Comparator: Optimal Booster - Participants in this group will be randomised to either standard radiotherapy plus SBRT (45 Gy in 20 fractions plus 20-30 Gy in 2 fractions-Booster) or standard radiotherapy (60 Gy in 20 fractions). The allocation is 2 to 1. This means that two thirds of the participants on the trial will get the Booster arm and one third will get the standard fractions.


Treatment: Other: Optimal SBRT
Two thirds of the participants in this group will get the SBRT (5 treatments) and one third will get standard treatment (60 Gy in 20 treatments)

Treatment: Other: Optimal Booster
Two thirds of the participants in this group will get the two high precision radiotherapy plus 20 doses of standard external beam radiotherapy (ie the "Booster approach|") and one third will get the standard treatment (60 Gy in 20 treatments)

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

Outcomes
Primary outcome [1] 0 0
local control - the rate of local control as determined on PSMA scanning
Timepoint [1] 0 0
12 months post radiotherapy
Secondary outcome [1] 0 0
Biological failure rate - The rate of biochemical failure defined as Nadir+2.0 biochemical failure defined as Nadir+2.0
Timepoint [1] 0 0
3 year and 5 year
Secondary outcome [2] 0 0
late toxicity - Late Gastrointestinal and Genitourinary Toxicity (modified RTOG scale)
Timepoint [2] 0 0
more than three months after treatment completion.
Secondary outcome [3] 0 0
Markerless tracking technology - Markerless tracking algorithms will be assessed for accuracy against marker-based localisation by masking the markers and directly comparing the determined trajectories
Timepoint [3] 0 0
During radiotherapy treatment
Secondary outcome [4] 0 0
Accuracy of the various intrafraction guidance methods - Accuracy of various intrafraction guidance methods will be determined against triangulation of kilovoltage (kV) and Megavoltage (MV) projections
Timepoint [4] 0 0
During radiotherapy treatment

Eligibility
Key inclusion criteria
Inclusion criteria

- Histologically proven prostate adenocarcinoma

- PSA obtained within three months prior to enrolment

- ECOG performance status 0 to 2

- Ability to understand and the willingness to sign a written consent

- Suitable for high dose irradiation to the prostate

To be eligible for the arm containing Stereotactic Booster alone approach patient must have
the following

- No contraindication to MRI such as pacemaker and severe claustrophobia

- Patient must be able to have fiducial markers placed in the prostate

- Patient must be able to have hydrogel insertion at the same time as fiducial markers

- Must have IPSS less than 15
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

- Previous pelvic radiotherapy

- Prior total prostatectomy

- Unwilling or unable to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Not Applicable
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
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

Ethics approval
Ethics application status

Summary
Brief summary
To compare the toxicity, rate of local control, biochemical failure rate and quality of life
of three different radiotherapy techniques (moderate hypofractionation, stereotactic body
radiotherapy (SBRT) and standard radiotherapy plus 2 fractions of SBRT (BOOSTER)
Trial website
https://clinicaltrials.gov/show/NCT03386045
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Kneebone, MBBS
Address 0 0
Northern Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carol Kwong
Address 0 0
Country 0 0
Phone 0 0
+61 2 9463 1339
Fax 0 0
Email 0 0
carolyn.kwong@health.nsw.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03386045