Optimal Prostate Study
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Optimal BoosterRadiation: Optimal SBRT
- Registration Number
- NCT03386045
- Lead Sponsor
- Royal North Shore Hospital
- 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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 214
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optimal Booster 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 SBRT 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.
- Primary Outcome Measures
Name Time Method local control 12 months post radiotherapy the rate of local control as determined on PSMA scanning
- Secondary Outcome Measures
Name Time Method Accuracy of the various intrafraction guidance methods During radiotherapy treatment Accuracy of various intrafraction guidance methods will be determined against triangulation of kilovoltage (kV) and Megavoltage (MV) projections
late toxicity more than three months after treatment completion. Late Gastrointestinal and Genitourinary Toxicity (modified RTOG scale)
Biological failure rate 3 year and 5 year The rate of biochemical failure defined as Nadir+2.0 biochemical failure defined as Nadir+2.0
Markerless tracking technology During radiotherapy treatment Markerless tracking algorithms will be assessed for accuracy against marker-based localisation by masking the markers and directly comparing the determined trajectories
Trial Locations
- Locations (1)
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia