| | Requirement |
| 1 | Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or RT |
| 2 | Biochemical progression (rising PSA) after medical or surgical castration |
| 3 | High risk of systemic progression |
| 4 | No evidence of local recurrence or distant metastases within 1 month of enrollment (or following enrollment as part of screening) including: [1] Radionuclide bone scan without evidence of metastatic disease; [2] CT or MRI of abdomen/pelvis without evidence of metastatic disease or recurrent disease in the prostate or prostate bed; [3] CXR or CT of chest without evidence of metastatic disease |
| 5 | At least 18 years of age |
| 6 | ECOG performance status < / = 2 |
| 7 | Life expectancy at least 12 months |
| 8 | AGC = / > 2.0; platelets = / > 150,000; Hgb = / > 10 or Hct = / > 30% |
| 9 | SGOT < / = 2 x uln; total bilirubin < / = 1.5 x uln (subjects with Gilbert’s syndrome will be allowed if direct bilirubin is wnl) |
| 10 | Creatinine < / = 2.5 |
| 11 | Serum calcium < / = 11 |
| 12 | PT or INR, PTT < / = 1.3 x uln (unless on therapeutic anti-coagulation) |
| 13 | Serum testosterone <50 ng/ml |
| 14 | Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial |
| 15 | Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy >4 weeks prior to protocol therapy. Initiation of bisphosphonate therapy is not allowed during the treatment phase. |
| 16 | Signed an approved study-specific informed consent and HIPAA |
| 1 | Use of red blood cell or platelet transfusions within 4 weeks of treatment |
| 2 | Use of hematopoietic growth factors within 4 weeks of treatment |
| 3 | Prior cytotoxic chemotherapy and/or RT within 4 weeks of treatment |
| 4 | Prior RT encompassing >25% of skeleton |
| 5 | Prior treatment with 89Strontium or 153Samarium containing compounds (e.g., Metastron, Quadramet) |
| 6 | Active serious infection |
| 7 | Active angina pectoris or NYHA Class III-IV |
| 8 | History of DVT and/or PE within 1 month of study entry |
| 9 | Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study. |
| 10 | Prior investigational therapy (medications or devices) within 4 weeks of treatment. Furthermore, other investigational therapy is not permitted during the treatment phase. |
| 11 | Prior use of ketoconazole for the purposes of prostate cancer therapy |
| 12 | Known history of HIV |
| 13 | Currently active other malignancy other than non-melanoma skin cancer |
| 14 | Adrenal hormone inhibitors (other than ketoconazole) within 4 weeks prior to study enrollment |
| 15 | Finasteride ((Propecia or Proscar) or dutasteride (Avodart) within 4 weeks of enrollment |
| 16 | Finasteride ((Propecia or Proscar) or dutasteride (Avodart) within 4 weeks of enrollment |
