This trial aims to examine stereotactic radiosurgery guided by an imaging technique in treating low- to intermediate-risk prostate cancer. The main outcome to be investigated is treatment-related side effects and treatment response. The trial is recruiting in Ohio (USA).
Stereotactic radiosurgery (SRS) uses a specially designed coordinate system for the exact localization of the tumors in the body in order to target radiation therapy precisely at the tumor. Magnetic resonance imaging (MRI) is a non-invasive method to provide a visual representation of the interior of the body. MRI can provide the coordinate-system used by SRS to help find the exact location of the tumor.
This study will evaluate MRI-guided SRS as a treatment for low- to intermediate-risk localized (confined) prostate cancer. Side effects related to the bowels, urinary function, stomach, and digestive system will be assessed for up to 1 year after treatment. Treatment response (based on blood test) will be recorded for up to 2 years. The effect of treatment on average survival and disease progression will also be calculated.
Who are they looking for?
This study will recruit about 12 men with low- to intermediate-risk localized prostate cancer. Participants must have undergone a bone scan within 90 days of taking part as well as a physical examination with rectal exam of the prostate. Participants must be able to undergo an MRI.
Patients cannot take part in the trial if the cancer has spread outside the prostate. Previous treatment with surgery, cryotherapy, radiation therapy, high-intensity focused ultrasound, hormone therapy (including testicle removal), chemotherapy, or experimental drug is not permitted. Drug therapies (such as finasteride[Propecia] or dutasteride[Avodart]) should be discontinued for 30 to 90 days before taking part (depending on the drug). Participants should not have any heart disease, bacterial or fungal infections requiring treatment, poor liver function, AIDS, any severe respiratory illness, or any other uncontrolled medical condition.
How will it work
All participants will undergo treatment with MRI-guided SRS. Participants will undergo 3 fractions of MRI-guided SRS every other day for 1 week. An additional MRI scan will take place between the 2nd and 3rd fractionated treatment, at 6 months following the end of radiation therapy, and again at 12 and 24 months. After the end of treatment, patients are followed up every 3 months for up to 24 months.
Side effects related to the bowels, urinary function, stomach, and digestive system will be assessed for up to 1 year after treatment by physical examinations and questionnaires. Treatment response (based on blood test) will be recorded for up to 2 years. The effect of treatment on average survival and disease progression will also be calculated for up to 2 years.