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)
Participants must have histologically proven prostate adenocarcinoma, good performance status and suitable for high dose radiotherapy. There are two groups of participants: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
503
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)
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)
Royal North Shore Hospital
St Leonards, New South Wales, Australia
local control
the rate of local control as determined on PSMA scanning
Time frame: 12 months post radiotherapy
Biological failure rate
The rate of biochemical failure defined as Nadir+2.0 biochemical failure defined as Nadir+2.0
Time frame: 3 year and 5 year
late toxicity
Late Gastrointestinal and Genitourinary Toxicity (modified RTOG scale)
Time frame: more than three months after treatment completion.
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
Time frame: During radiotherapy treatment
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
Time frame: During radiotherapy treatment
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