A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence

Inclusion Criteria:

• Over or equal to 18 years of age.
• ECOG performance status less than or equal to 1
• Adequate organ function.
• History of radical prostatectomy with histopathologic documentation of adenocarcinoma of the prostate.
• PSA over or equal to 0.2 ng/ml or less than or equal to 0.4 ng/ml. This includes patients whose PSA never becomes detectable. PSA progression must be measured by two consecutive samples, each separated by over or equal to 7 days. The PSA values of the two consecutive sample values must be greater than the previous (baseline) value, not greater than each other.

Exclusion Criteria:

• Known sites of measurable prostate cancer or bone scan positive for metastatic prostate cancer. (patients with a positive Prostascint scan will not be excluded)
• Prior therapy for prostate cancer except RP and neoadjuvant hormonal therapy. This includes chemo, hormonal (except neoadjuvant), RT, and biologic therapy.
• Lack of physical integrity of the upper GI tract, malabsorption syndromes, or inability to tolerate or absorb oral medications, including Crohn's disease and ulcerative colitis.
• Other concurrent immunotherapy, RT, chemotherapy,or ancillary therapy considered investigational (utilized for non-FDA approved indications and the context of a research investigation)and any chemotherapy not included in the study protocol.