A Pilot Study of patients with Oligometastases from Prostate cancer treated with Stereotactic Ablative Body Radiosurgery

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This study is assessing the feasibility and safety of Stereotactic Ablative Body Radiosurgery (SABR) in patients with metastatic prostate cancer. Who is it for? You may be eligible for this study if you have Prostate Cancer that has spread to lymph nodes or the bones. Trial Details: The research project is testing a new treatment for prostate cancer that has spread beyond the prostate to the lymph nodes or bones. The new treatment is called Stereotactic Ablative Body Radiotherapy. Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy. Stereotactic Ablative Body Radiotherapy (SABR) appears to be effective in controlling cancer in other sites elsewhere in the body, including the lung, kidney and the liver. We aim to test the ability of this new technique to control cancers arising from the prostate, and that have spread to bone or lymph nodes. As part of this study you will be required to discuss your past medical history and progress of your prostate cancer with the doctor. A general physical examination with a focus on where the cancer has spread to is part of the study. You will have standard blood tests including your hormone levels and prostate specific antigen (PSA) level. Also as part of this study you will be required to have a special scan called an 18F-PET/CT (stands for fluoride-positron emission tomography/computer tomography) scan. This involves an injection of a radioactive chemical and then a scan to see where your prostate cancer has spread to. If the tests show that the research study is suitable for you, and you still wish to take part, you can join the study and begin the treatment. Prior to your stereotactic body radiotherapy you will be required to fill out quality of life and pain questionnaires. This may take up to 20 minutes of your time. You will have either a single session of stereotactic body radiotherapy (SABR) or in the rare situation where there is not enough time available you may be required to return for two sessions (if you have two lesions) and three sessions (if you have three lesions). In order to deliver this treatment, you will need to attend a ‘planning CT scan’ session, where you will receive a CT scan and your body measurements are taken in the position that you will be lying in for your radiotherapy. This visit takes approximately one hour. Once the radiotherapy treatment has been planned, a further ‘mock-up’ visit is required to ensure that the radiotherapy plan can be smoothly delivered when it comes to the time of treatment. This session will take between 45 minutes and 90 minutes. When the treatment starts, the total time required to deliver the treatment will be approximately one hour. All sessions are usually conducted on different days and we will contact you to give you the dates and times to attend for these sessions once they have been booked for you. Follow-up will involve a visit at approximately 1 month, and every 3 months until two years after the radiotherapy treatment. At each visit you will be reviewed by the doctor and have a prostate blood test (PSA). At each visit you will be expected to indicate on a questionnaire if you have any pain. At the 1, 3, 12 and 24 month visits you will be expected to fill out a quality of life questionnaire which will take about 20 minutes of your time. You will have a whole body bone scan at 12 or 24 months after your treatment. At 6 months after your radiotherapy treatment you will have another 18F-PET/CT scan, which will be very similar to the scan before your treatment. The purpose of this scan is to assess the effect of the treatment on your lesion(s).

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