This trial is aiming to investigate the effectiveness of stereotactic body radiotherapy (SBRT) boost for the treatment in patients with high-risk prostate cancer (PCa). The main outcome that will be measured will be the quality of life (QoL) of patients. This study is being carried out in Ontario, Canada.
The details
PCa is the most common form of cancer in men. It is a cancer that forms from the cells of the prostate gland. High-risk PCa has a higher risk of recurrence after initial treatment. SBRT is a form of radiation therapy that is delivered in small intense doses in order to spare healthy surrounding tissue and kill cancerous cells. A radiotherapy boost is an extra dose of radiation applied at the initial tumor site. It aims at killing any small cancer cells that remain after initial treatment.
This study is being carried out to assess QoL in patients up to 6 months after SBRT boost in patients with high-risk PCa.The main outcome that will be measured is the short-term QoL up to 6 months after radiotherapy.
Who are they looking for?
This study is looking to recruit 100 patients with high-risk PCa. Participants must not have cancer spread to other organs or tissues and must be able to complete QoL questionnaires in English.
Patients diagnosed with PCa more than 6 months prior to registration in the trial, who had previous radical treatment for PCa (such as surgery, radiotherapy, or removal of the testicles), and patients who have previously received 12 or more weeks of hormone therapy cannot participate. Patients with a history of other forms of cancer will also be excluded from this trial. Patients who had a hip replacement, inflammatory bowel disease, or a PSA level over 50 cannot participate.
How will it work
There are two groups in this study. All participants will receive 3 months of hormonal therapy, followed by standard pelvic radiotherapy. Hormonal therapy will continue for all patients for up to 3 years. After radiotherapy. one group will receive a conventional radiotherapy boost consisting of 16 doses of radiotherapy 5 days a week, over 22 days. The second group will receive a SBRT boost consisting of 3 doses of radiation, one per week over 22 days.
The follow-up for patients to measure outcomes will be up to 24 months. The outcomes to be measured are short-term QoL, long-term QoL, urinary function, and toxicity.
