This trial is examining the effectiveness of radical prostatectomy, in newly diagnosed advanced prostate cancer. The main outcome to be measured will be survival without the cancer worsening. This trial is recruiting in the United States.
Androgens can cause the growth of prostate cancer cells. Antiandrogen therapy (ADT) may reduce the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel (Taxotere) work in different ways to stop the growth of tumor cells. These work by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Surgery, ADT and docetaxel may work better in treating patients with prostate cancer.
This trial is examining the effectiveness of prostate surgery with ADT with or without docetaxel in newly diagnosed advanced prostate cancer. The main outcome to be measured will be survival without the cancer worsening.
Who are they looking for?
This study requires 190 patients with newly diagnosed metastatic prostate cancer. The prostate must be suitable for surgical removal. Patients must have adequate blood cell counts, liver and kidney function tests. Life expectancy must be longer than 6 months.
Patients must not have started ADT longer than 6 months before the trial. Patients must not have spinal cord compression or a recent history (in the previous 6 months) of a blood clot in the deep veins or lungs. Patients who have chemotherapy, radiotherapy or oral antifungal medications within 3 weeks before starting the study will be excluded.
How will it work
There will be two groups in this study. One group will receive ADT with or without docetaxel. The second group of patients will receive ADT for at least 1 month. They will then undergo prostate removal surgery. All patients will continue ADT and may receive docetaxel within 3 months after surgery. After completion of the treatment, patients are followed up every 6 months for up to 4 years.