This trial evaluates the effectiveness of radiation therapy delivered from outside the body for the treatment of prostate cancer. The main outcomes of this trial are the number of patients who have no damage to genital or urinary organs and survival without cancer. This trial is taking place in various sites across the USA and Canada.
Radiation therapy is one of the treatment options for patients with prostate cancer. It uses radio waves to kill the cancerous prostate tissue. Radiation can be given from outside the body (stereotactic body radiation therapy). Stereotactic body radiation therapy (SBRT) can cause less damage to surrounding tissues. Radiation therapy can also be delivered in different strengths to different areas of target organ (intensity-modulated radiation therapy or IMRT).
This trial is evaluating SBRT and comparing it to IMRT. The main outcome of this trial is the number of patients who have no damage to genital or urinary organs during radiation therapy. Survival without cancer and overall survival will also be measured.
Who are they looking for?
622 patients are needed for the trial. To be included in the study, patients receiving 5-alpha-reductase inhibitors should stop this treatment. Patients must have an MRI of the pelvis, bone scan or PET scan within 90 days before the trial starts
Patients will not be included in the study if they have HIV, if they have or have had another cancer in the past 3 years or if they have damaged liver function resulting in clinical jaundice and/or coagulation defects. Patients must not have a cardiac stimulator or defibrillator, any surgically implanted electrical devices such as spinal stimulation devices or intracranial stimulation devices, ear implants, metallic foreign bodies, and old mechanical heart valves and aneurysm clips.
How will it work
Patients will be randomly assigned to one of two groups. Patients will receive either IMRT or SBRT. Patients will have follow-up visits every 6-12 months for up to 5 years. Patients will be assessed for damage to the tissue around their genital and urinary organs and other side effects. Survival and quality of life will also be measured.