Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer

Inclusion Criteria

• •Pathologic proof of adenocarcinoma of the prostate.
• •Patients must belong to one of the following subsets:
• •Prior local therapy
• •Patients with Prostate Specific Antigen (PSA) recurrence following prostatectomy or radiation therapy who have no radiographic involvement. PSA doubling time ≤6 months.
• •Nodal involvement only.
• •Low volume bone disease: ≤3 metastases.
• •Nodal involvement with associated bone involvement.
• •High volume bone-visceral disease: Patients with \>3 metastatic bone sites or visceral metastases.
• •No prior definitive local therapy
• •Tumors felt to be unresectable, not candidates for radiation therapy, and PSA elevated with biopsy-proven disease.
• •Metastatic disease at presentation.
• •Patients may have started ADT within 3 months of study entry.
• •No previous cytotoxic therapy is allowed, including systemic irradiation with strontium-89, samarium, or radium-223.
• •Previous definitive radiotherapy to one metastatic site is acceptable, provided that unirradiated sites remain. At least 8 weeks must have elapsed since radiation therapy to the pelvis. Patients having limited irradiation of a metastatic site are eligible 4 weeks following radiation.
• •Patients may have had previous exposure to ADT if it was given for ≤6 months to "downstage" the primary and provided that such therapy was completed at least 12 months prior to entry into this study with a return of serum testosterone to ≥200 ng/dL.
• •Patients must be free of serious comorbidity and have a life expectancy of ≥3 years.
• •Patients must have adequate physiologic reserves as evidenced by:
• •Eastern Cooperative Oncology Group (ECOG) status of ≤2.
• •Patients must have adequate bone marrow function: Platelets ≥100,000 cells/mm3, Hemoglobin ≥9.0 g/dL, and Absolute Neutrophil Count (ANC) ≥1,500 cells/mm3.
• •Patients must have adequate renal function: creatinine ≤2 × upper limit of normal (ULN).
• •Patients must have adequate liver function: Aspartate aminotransferase (AST) / Alanine transaminase (ALT) ≤2.5 × ULN; alkaline phosphatase \<2.5 × ULN, unless bone metastasis is present in the absence of liver metastasis; and bilirubin \< ULN or 1.5 mg/dl.
• •No evidence of active ischemia on electrocardiogram (ECG) and documentation of ejection fraction (EF) ≥50%.