| | Requirement |
| 1 | Male, 21 y/o and above |
| 2 | Must have serum PSA more than or equal to 2 ng/mL (*see exception for Group II) |
| 3 | Must have rising serum PSA level (defined as at least 2 consecutive rises in PSA documented over a reference value)
***1st measure (as reference value) : must be w/i 3 months prior to enrollment
***2nd measure (first rising PSA ): must be 14 days or more after the reference value
***3rd measure (confirmatory PSA) : must be 14 days or more after the 2nd measure & must be greater than the 2nd measure.
|
| 4 | Serum Creatinine must be less than or equal to 2.5 x ULN and must be w/i 28 days of enrollment |
| 5 | Prior surgery allowed (must have completed surgery more 14 days prior to study treatment & must have recovered from any side effects) |
| 6 | Men of childbearing potential must use effective contraception |
| 7 | OPTIONAL: Completed baseline McGill Pain Questionnaire and analgesic pain survey |
| 8 | Group I (hormone-naïve) inclusion criteria:
•must have histological diagnosis of prostate adenocarcinoma, must be currently metastatic (TxNxM1) & is hormone-naïve
•Must have conventional imaging evidence for metastatic disease by CT, bone scintigraphy or both.
|
| 9 | Group II (hormone-refractory) inclusion criteria:
•must have histological diagnosis of prostate adenoca, must be currently metastatic (TxNxM1) & is unresponsive or refractory to hormonal treatment.
•Progression of measurable disease assessed with CT or bone scan w/i 3 months
•*No minimum PSA level is required if clinically symptomatic patients (e.g. metastasis-related bone pain)
•Must have received prior hormonal therapy & must have castrate level of testosterone (pts treated with orchiectomy are eligible)
|
| 10 | Must sign Informed Consent (including HIPAA authorization) |
