Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone aganist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen deprivation therapy is more effective for prostate cancer.
This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer. Patients will be randomly assigned to one of three study groups: radiation therapy to the prostate bed only; hormone therapy plus radiation to the prostate bed; and hormone therapy plus radiation to the prostate bed and to the pelvic lymph nodes.
The purpose of this study is to provide an experimental drug called Yondelis to eligible patients who have not responded to previous treatment. This drug has not been approved for sale by the FDA for use with your type of cancer. Safety evaluation of this drug will also occur during this study that will include physical exams, monitoring of your vital signs and side effects, and performing laboratory tests.
Patients who participate in this study will receive Yondelis as a 24-hour infusion. You may be hospitalized only for the first cycle of this treatment. You will receive treatment on day 1 of every 17 to 49 day cycle. You will visit your doctor on day 1 of each cycle and blood will be taken during the middle of each cycle and at the end of treatment.