Digoxin for Recurrent Prostate Cancer

Inclusion Criteria

• There must be a confirmed biochemical progression. Biochemical progression is defined as three rises in PSA levels, with each PSA determined at least 4 weeks apart, and each PSA value increase >0.2 ng/ml.
• Baseline PSA must be determined within 4 weeks of study entry. At least 3 PSA values are necessary prior to the study entry to calculate PSA doubling time (PSADT) calculator.
• Men with history of radical prostatectomy are required to have baseline PSA >1 ng/ml. Men treated with primary radiation therapy are required to have baseline PSA>2 ng/ml and greater than 150% rise from postradiation nadir.
• PSA doubling time must be between 6 and 24 months.
• All treatments including intermittent hormonal therapy must have been discontinued for > 6 months prior to study entry.
• No clinical or radiological evidence of distant metastases
• ECOG 1 ng/ml. Men treated with primary radiation therapy are required to have baseline PSA>2 ng/ml and greater than 150% rise from postradiation nadir
• 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 at: http://www.mskcc.org/mskcc/applications/nomograms/PSADoublingTime.aspx. PSA doubling time must be between 6 and 24 months.
• All previous local modalities of treatment, including radiation and surgery, must have been discontinued at least 8 weeks prior to treatment in this study. Patients may have received prior systemic chemotherapy, hormonal therapy, biologic or vaccine therapy. All systemic treatments must have been discontinued for > 6 months prior to study entry.
• Patients receiving intermittent hormonal therapy for their rising PSA state are considered eligible if testosterone level is above 150ng/dl and treatment was discontinued > 6 months and agree not to have additional injections while on study drug.
• No 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). Lymph node up to 2 cm size is allowed for the study.
• ECOG 70% within 14 days before being registered for protocol therapy (Appendix B)
• Normal organ function with acceptable initial laboratory values:
• Absolute neutrophil count ≥ 1 x 109/L
• Platelets > 50 x 109/L
• Creatinine 2 treatment-related toxicity from prior therapy
• History of any digoxin-related or drug induced anaphylactic reaction
• Receipt of another investigational agent within 6 months of study entry. Patient must have recovered from all side effects of prior investigational therapy.