Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
503 participants
INTERVENTIONAL
2018-10-02
2028-08-01
Brief Summary
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Detailed Description
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Group 1: eligible participants will be randomised to have either moderate hypofractionation or standard radiotherapy plus SBRT (BOOSTER). Participants in this group must be able to have MRI, prostate fiducial markers (gold markers)and hydrogel insertion. Fiducial markers will be used to locate the prostate accurately during radiation treatment. Hydrogel is a temporary gel being injected into the space between the prostate and rectum to reduce the dose of radiation received by the rectum to minimise side effects from the treatment.
Group 2: eligible participants will be randomised to have either moderate hypofractionation or SBRT.
Participants will be reviewed for side effects. A Safety Committee will be formed containing multi-disciplinary team members. All serious adverse will be reported to the principal investigator and Human Research Ethics Committee within 24 hours.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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)
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.
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)
Interventions
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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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Prior total prostatectomy
* Unwilling or unable to give informed consent
18 Years
MALE
No
Sponsors
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Royal North Shore Hospital
OTHER
Responsible Party
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Principal Investigators
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Andrew Kneebone, MBBS
Role: PRINCIPAL_INVESTIGATOR
Northern Sydney Local Health District
Locations
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Royal North Shore Hospital
St Leonards, New South Wales, Australia
Countries
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Other Identifiers
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OPTIMAL
Identifier Type: -
Identifier Source: org_study_id
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