Description: |
This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.
Patients must have histologically or cytologically confirmed prostate cancer with metastatic disease. Patients may have started hormonal therapy, but not more than 120 days prior to randomization. Patients will be stratified by presence of low volume disease (metastatic disease that is not extensive) or high volume disease (any visceral metastases and/or at least four bone lesions, one of which must be outside the spinal column or pelvis). PSA must not have risen from its lowest point between the beginning of androgen deprivation and the date of randomization. Patients must have discontinued hormonla therapy in the adjuvant and/or neoadjuvant setting 12 months prior to beginning protocol therapy and must must have exceeded 24 months of therapy and must have been NED for at least 12 months after completing adjuvant or neoadjuvant hormonal therapy. No prior chemotherapy in the adjuvant or neoadjuvant setting. No prior hormone therpay in the metastatic setting. |