This trial is examining the effectiveness of ultra-high-dose hypofractionated or single-dose radiotherapy for intermediate (medium) risk prostate cancer. The main outcome that will be measured will be the number of patients that experience side effects. This study is being conducted in New York City, NY, the US.
Ultra-high-dose hypofractionated radiotherapy (UHD-HFRT) involves the use of high doses of radiation per one treatment session (fraction) to treat cancer. Image-guided RT (IGRT) allows improved control over daily treatment setup and dose delivery to the target organ. This limits side effects to the surrounding organs.
This study will compare the effects of UHD-HFRT and single-dose RT for prostate cancer. The main outcome that will be measured will be the number of patients that experience side effects in the 5 years after treatment.
Who are they looking for?
This study will recruit 30 participants. Patients with intermediate-risk prostate cancer, as confirmed by biopsy will be included. The prostate cancer stage must have also been confirmed by magnetic resonance imaging (MRI).
Patients who have had another cancer in the 5 years before the study or who received surgery or RT for prostate cancer will not be included. Those with a serious medical condition, bowel inflammatory disease or severe psychiatric illness will not be included. Men with prostates larger than 100 grams will not be included.
How will it work
Participants will be split into two groups. Those in group 1 will receive hypofractionated IGRT at 45 Gy in 5 fractions of 9 Gy. This will be administered over 5 days in a row. They will also receive dexamethasone (Decadron) on the days they receive RT and tamsulosin (Flomax) every day after RT for 2 weeks.
Those in group 2 will receive a single 24 Gy dose of IGRT. This will be followed by the same treatment with dexamethasone and tamsulosin as those in group 1.
Patients will be followed up for up to 5 years for side effects quality of life and response to treatment.