Prostate Cancer
Conditions
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.
Interventions
RADIATIONOptimal 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)
RADIATIONOptimal 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)
Sponsors
Royal North Shore Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Previous pelvic radiotherapy * Prior total prostatectomy * Unwilling or unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| local control | 12 months post radiotherapy | the rate of local control as determined on PSMA scanning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| late toxicity | more than three months after treatment completion. | Late Gastrointestinal and Genitourinary Toxicity (modified RTOG scale) |
| 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 |
| 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 |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORAndrew Kneebone, MBBS
Northern Sydney Local Health District
Outcome results
None listed