Procedures
ADVERSE EVENTS, BLOOD, DISEASE
Patients received treatment with satraplatin 80 mg/mPatients were discontinued from the study if they demonstrated PSA progression while on satraplatin, defined as a ≥25% PSA increase from either nadir or pretreatment value (whichever is lower) and a minimum absolute PSA increase by ≥2 ng/mL. Patients had to have been on treatment for at least 2 cycles in order to be evaluable for PSA progression, and PSA values had to be confirmed at least 3 weeks later. Other grounds for discontinuation of study were the development of significant adverse events or toxic effects, where continued administration of the study drug was deemed not to be in the patient’s best interest.Follow-up visits for evaluation and safety checks were scheduled to coincide with the start of each 35–day cycle. Blood samples to establish serum PSA, blood count, renal and hepatic function were collected at screening, on day 1, and every 5 weeks at the start of each new treatment cycle. Radiologic studies (CT or MRI of chest, abdomen, and pelvis, plus bone scan) to evaluate for interval changes in disease were performed every 2 treatment cycles.As part of scientific correlative endpoints, serum as well as whole blood in PAXgene Blood RNA tubes were collected at the time of enrollment (pre-treatment), prior to cycle 10 (on-treatment), and upon progression.