Study of Recurrent Prostate Cancer With Rising Prostate Specific Antigen (PSA)

Inclusion Criteria

• •Provide written informed consent and HIPAA authorization for the release of personal health information.
• •Adult male ≥18 years of age
• •No desire to drink any alcohol during the study period. (The potential for ethanol interactions may last 7 to 14 days. Patient is allowed to drink alcohol 2 weeks after the study is finished)
• •Histological confirmed diagnosis of adenocarcinoma of the prostate (M0) with evidence of biochemical relapse after local therapy (i.e., surgery, radiation therapy, or both). Baseline PSA must be ≥ 1 ng/ml.
• •There must be a confirmed rise in PSA shown by 2 PSA values at least 1 week apart, higher than a reference value noted within 12 months of study entry. Interim PSA values during the immediate pre-study 12-month interval may demonstrate a "fluctuation" including a decline; however the study baseline PSA must have show a rise within the pre-study 12-months period. Baseline PSA must be determined within 4 weeks of study entry. At least 3 PSA values are necessary to calculate PSA doubling time via PSADT calculator.
• •All previous local modalities of treatment, including radiation and surgery, must have been discontinued at least 4 weeks prior to treatment in this study. Patients may have received prior systemic chemotherapy, hormonal therapy, biologic or vaccine therapy
• •No history of or current clinical or radiological evidence of distant metastases (excluding prostascint scan/PET in absence of radiographic disease in Bone scan, CT scan or MRI if used). Retroperitoneal/pelvic lymph node up to 2 cm size is allowed for the study.
• •ECOG performance score \< 2 within 14 days before being registered for protocol therapy
• •Normal organ function with acceptable initial laboratory values:
• •* Absolute neutrophil count ≥ 1 x 109/L
• •* Platelets \> 50 x 109/L
• •* Creatinine \<2 mg/dL
• •* Bilirubin \<1.5 X ULN (institutional upper limits of normal)
• •* AST (SGOT) and ALT (SGPT) ≤ 1.5 x ULN
• •* Willingness to use adequate methods of contraception throughout study participation and for at least 3 months after completing therapy