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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimal SBRT | Active Comparator | 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 Booster | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimal SBRT | Radiation | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| local control | the rate of local control as determined on PSMA scanning | 12 months post radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Biological failure rate | The rate of biochemical failure defined as Nadir+2.0 biochemical failure defined as Nadir+2.0 | 3 year and 5 year |
| late toxicity | Late Gastrointestinal and Genitourinary Toxicity (modified RTOG scale) |
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Inclusion criteria
To be eligible for the arm containing Stereotactic Booster alone approach patient must have the following
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Kneebone, MBBS | Northern Sydney Local Health District | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
aim to present study data in conferences and medical journals
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end of trial after analysis
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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no masking
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| Optimal Booster | Radiation | 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) |
|
| 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 | 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 | During radiotherapy treatment |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |