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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03386045
Ethics application status
Date submitted
11/12/2017
Date registered
29/12/2017

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
Timepoint [1] 0 0
12 months post radiotherapy
Secondary outcome [1] 0 0
Biological failure rate
Timepoint [1] 0 0
3 year and 5 year
Secondary outcome [2] 0 0
late toxicity
Timepoint [2] 0 0
more than three months after treatment completion.
Secondary outcome [3] 0 0
Markerless tracking technology
Timepoint [3] 0 0
During radiotherapy treatment
Secondary outcome [4] 0 0
Accuracy of the various intrafraction guidance methods
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
Sex
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
2/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2028
Actual
Sample size
Target
214
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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT03386045