This trial evaluates the effectiveness of using chemotherapy in combination with radium-223 (a type of internal radiotherapy). The main outcome to be measured is overall survival. This trial is taking place in the 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 prostate cancer cells chemically. Surgery aims to cut out the cancerous prostate tissue. Radiation therapy uses radio waves to kill the cancerous prostate tissue. Sometimes a combination of these treatments can work best to treat prostate cancer.
This trial looks at using docetaxel (Taxotere) chemotherapy and radium-223, a type of internal radiotherapy to treat advanced prostate cancer. It compares using both radiotherapy and chemotherapy to using chemotherapy alone. The main outcome to be measured is overall survival.
Who are they looking for?
738 patients are needed for this trial. To be included in this trial, patients must have prostate cancer that keeps growing in spite of hormone therapy. Patients must have two or more bone lesions. Patients must have normal blood cell counts and adequate kidney and liver function tests. Patients must agree to use acceptable birth control during the study and up to 30 days after the last dose of study drug. Patient's testosterone levels must be less than 50 ng/dL. Patients must continue hormone suppression with an LHRH analogue if they have not had their testicles removed.
Patients cannot be included in the study if they have received radiotherapy in the past. Patients cannot have received four or more treatments for advanced prostate cancer growing after hormonal therapy. Patients cannot have had blood transfusions or growth factors within the last 4 weeks before randomization. Patients cannot have had another cancer in the past 3 years. Patients cannot have spinal cord compression identified from clinical findings and/or MRI. Patients cannot have abnormal bone marrow cells. Patients cannot have had 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods such as phytoestrogens or other food supplements known to alter PSA in humans, in the 4 weeks before the trial begins. Patients cannot have an uncontrolled infection, heart failure or inflammatory bowel disease.
How will it work
Patients will be divided into two groups. Group 1 will receive docetaxel 75 mg/m2 every 3 weeks for 10 doses. Group 2 will receive docetaxel 60 mg/m2 every 3 weeks for 10 doses and radium-223 injections every 6 weeks. Patients will be followed up for 2 years.
