This study evaluates the effectiveness of medication and focal radiation in the treatment of prostate cancer resistant male hormone suppression. The main outcome to be measured in this trial is the number of patients whose cancer does not grow or spread and who are alive at 18 months after treatment. This trial is taking place in Ann Arbor, Michigan, United States.
The details
Prostate cancer is an uncontrolled growth of the cells which make up the prostate gland. Prostate cancer can be treated by medication, surgery or radiation. Medication aims to kill the prostate cancer cells chemically. Surgery aims to cut out the cancerous prostate tissue. Focal radiation therapy uses radio waves to kill the cancerous prostate tissue. The radiation beam is delivered to the tumor from multiple directions.
This trial aims to evaluate if medication in combination with focal radiation therapy can prolong survival time. The main outcome to be measured in this trial is the number of patients whose cancer does not advance and who are alive at 18 months after treatment.
Who are they looking for?
This trial is looking for 72 participants with advanced prostate cancer. To be included in the study, patients must agree to stop taking medication 2 weeks before the beginning of the study. Patients must have a testosterone level of less than 50ng/dL. Patients cancer must have progressive disease based on prostate serum antigen (PSA; a blood test that indicates prostate cancer progression) increases by 25% or a growth of the tumor confirmed by MRI or CT scan, or progressive bone disease confirmed by a bone scan.
Patients cannot have had a history of cancer in the past three years or who have an uncontrolled illness. Patients cannot be included in the study if they are planning to have Radium-223 dichloride or sipuleucel-T. Patients cannot be included if they are unable to undergo radiotherapy, continuous treatment, CT or bone scans.
How will it work
Patients will be randomly assigned to one of two groups. Group 1 will receive drug therapy only. Group 2 will receive drug therapy and radiotherapy. Standard treatment will be decided by the patients' oncologist. Radiotherapy will be given within 8 weeks of the beginning of the study.
Patients response to treatment will be assessed. Progression of cancer will also be monitored in patients. This will be defined as an increase in the size of the tumor. Patients will be followed up to 24 months.
