Study of Individualized Amonafide to Treat Prostate Cancer

Inclusion Criteria:

* Men 18 years or older;
* Metastatic androgen-independent prostate cancer with evidence of progression;
* Zero or one prior course of chemotherapy for metastatic disease;
* Up to two prior courses of non-cytotoxic therapies for metastatic disease;
* Progressive measurable or assessable disease;
* Evidence of continued elevation of PSA despite antiandrogen withdrawal;
* ECOG Performance Status \< 2 with an expected survival of at least 6 months;
* Adequate renal function;
* Adequate hepatic function;
* Adequate hematologic status;
* No other prior malignancy is allowed except for the following: adequately-treated basal cell or squamous cell skin cancer, adequately treated Stage I or II bladder cancer from which the subject is currently in complete remission, or any other cancer from which the subject has been disease free for 5 years;
* Subjects must have recovered from all acute toxicities from prior treatment;
* Screening visit phenotyping procedures must have been completed successfully;
* No blood transfusion within the previous 2 weeks of signature of the informed consent;
* Expected cooperation of the subject for the treatment and follow up must be obtained and documented;
* Written informed consent must be obtained and documented.

Exclusion Criteria:

* Clinically significant abnormal hematological parameters other than those defined in the inclusion criteria;
* Clinically significant abnormal biochemical parameters other than those defined in the inclusion criteria;
* Subjects who have been receiving bisphosphonates for less than three months prior to the first Amonafide administration;
* Known history of brain metastases;
* Subjects who are HIV positive;
* Subjects who are hepatitis B surface antigen positive or have previously documented hepatitis C infection;
* Subjects who received treatment with Growth Factors (i.e. G-CSF, GM-CSF) within 2 weeks of the signature of the informed consent form;
* Subjects who had any major surgery within four weeks of first administration of Amonafide;
* Subjects with a history of a psychological illness or condition which may interfere with the subjects ability to understand or comply with the requirements of the study;
* Subjects who received an investigational new drug within 30 days of the first dose of Amonafide;
* Any other known condition, which in the investigator's opinion would not make the subject a good candidate for the trial.