None listed
Conditions
Brief summary
The aim of this study is to investigate the safety and feasibility of an advanced technique of external beam radiotherapy, termed stereotactic body radiotherapy (SBRT), in men with prostate cancer. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above who has a confirmed diagnosis of intermediate or high risk prostate cancer. Study details Studies have shown that escalated doses of radiotherapy increase cure rates for prostate cancer. Higher doses are achievable with high dose rate (HDR) brachytherapy, and data suggests outcomes are superior. However, HDR brachytherapy is invasive, expensive and requires access to operating theatres and specialised equipment. In this study we aim to investigate whether an advanced technique of external beam radiotherapy, termed stereotactic body radiotherapy (SBRT), is able to emulate the doses and outcomes of HDR brachytherapy while being a noninvasive technique that employs commonly available radiotherapy equipment. All participants in this study will receive SBRT and be monitored for up to five years. in order to evaluate treatment toxicity, feasibility and efficacy.
Interventions
Stereotactic body radiotherapy (SBRT) allows high doses of radiotherapy to be delivered using external beam radiotherapy to a similar dose that is achieved using brachytherapy. The study investigates if stereotactic radiotherapy can be as safe and as effective as brachytherapy without the need for an invasive surgical procedure involved with delivering brachytherapy. The main reason for this study is to try to replicate this technique in Australia using equipment available in all radiotherapy de
Stereotactic body radiotherapy (SBRT) allows high doses of radiotherapy to be delivered using external beam radiotherapy to a similar dose that is achieved using brachytherapy. The study investigates if stereotactic radiotherapy can be as safe and as effective as brachytherapy without the need for an invasive surgical procedure involved with delivering brachytherapy. The main reason for this study is to try to replicate this technique in Australia using equipment available in all radiotherapy departments. This study also includes a mechanism for SBRT dose escalation. A minimum of 20 men are to complete treatment without >15% suffering a grade 3 acute toxicity or any episodes of grade 4 acute toxicity at a particular dose level. The individual centre must also accrue >5 patients at the previous dose level prior to exploring dose escalation. Once this is satisfied the SBRT dose is to increase by 1Gy. The initial dose will be 19Gy, therefore the first dose escalation will be to 20Gy. This process can be followed a maximum of three times, to a maximum SBRT dose of 22Gy. Radiotherapy can cause damage to the lower part of the bowel, known as the rectum, which is right next to the prostate. Two methods are available to try to reduce the risk of any damage to the rectum by moving the rectum a little further away from the prostate. Firstly, a device called Rectafix could be used in this study to do this. It involves inserting a probe the same size as a finger into the back passage and using it to angle the rectum away from the prostate inserted only for the duration of the radiotherapy planning, and only for the duration of the two stereotactic radiotherapy treatments. Secondly, a water based gel called SpaceOAR could also be used in this study to do this. It involves inserting this gel in the space between the prostate and rectum 1-2 weeks before radiotherapy planning. Either of these rectal displacement techniques (Rectafix or SpaceOAR) will be utilised at the doctor's discretion in consultation with the participating patients. The stereotactic radiotherapy dose (given over two treatments one week apart) and the external beam dose (46Gy in 23 fractions or 36Gy in 12 fractions depending on the centre) is the same irrespective of the rectal separation technique employed.
Sponsors
Dr Mark Sidhom
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient capable of giving informed consent 2. Histological diagnosis of prostate cancer (PC) 3. Intermediate or High risk disease respectively defined by any one of: a.Baseline PSA 10-20, Gleason grade 7 disease, Clinical stage T2b-c OR b.Baseline PSA greater than or equal to 20, Gleason grade 8-10 disease, Clinical stage T3 4. For high risk patients, negative conventional staging in the form of a: a. PSMA PET scan OR b. T99m whole body bone scan AND b. Either CT of the abdomen and pelvis or MRI pelvis 5. No previous pelvic radiotherapy
Exclusion criteria
1. ECOG performance status >1 2. Hip prosthesis 3. Inability to have intraprostatic fiducials inserted. 4. Inability to have a MRI due to: a. Implanted magnetic metal eg intraocular metal b. Pacemaker / Implantable defibrillator c. Extreme claustrophobia 5. Clinical stage T4 (tumour invasion into adjacent anatomical structures) 6. Inflammatory bowel disease 7. Severe obstructive urinary symptoms 8. Inability to meet planning objectives
Outcome results
None listed