This phase 1/2 trial aims to evaluate the effectiveness of a short course of very focused radiation therapy in the treatment of early stage prostate cancer. The main outcome to be investigated is side effects and treatment response. The trial is recruiting in San Diego, California (USA).
External beam radiation therapy (EBRT) involves directing high-energy rays from outside the body at the tumor site to kill cancer cells. It is a common treatment of localized prostate cancer (cancer confined to the prostate gland). While EBRT is associated with good treatment effectivity, it can take up to 9 weeks to deliver. Stereotactic body radiation therapy (SBRT) is a type of EBRT that uses very focused radiation beams targeting a well-defined tumor. SBRT relies on detailed imaging, planning, and precise treatment set-up to deliver a high radiation dose with high accuracy (stereotactically).
This study will examine whether SBRT delivered over a short course (1 to 2 weeks) can be an effective alternative type of radiation therapy for early stage prostate cancer. Short- and long-term side effects will measure how well SBRT is tolerated. Treatment response will be measured using blood tests.
Who are they looking for?
This study will recruit about 10 men between the ages of 50 and 90 with localized, low risk prostate cancer. Previous biopsies should confirm less than 2 positive tissue samples (containing cancer cells). The tumor should have a volume of less than 5 mm.
Patients cannot take part in the trial if they have previously undergone prostate surgery or radiation therapy.
How will it work
All participants will receive 5 SBRT treatments over the course of 1 to 2 weeks. Side effects will be recorded over the course of 1 year and compared to those of standard radiation therapy. Blood tests measuring PSA levels (prostate-specific antigen, an indicator of prostate growth) will record treatment response 1 year after SBRT.