Prostate Cancer Clinical Trial
Official title:
A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients With Hormone Refractory Prostate Cancer Previously Treated With One Cytotoxic Chemotherapy Regimen
PURPOSE:
The SPARC trial is designed to compare the combination of the investigational oral cytotoxic
drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in
patients with hormone-refractory prostate cancer (HRPC).
TARGET PATIENT POPULATION:
The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC)
and whose disease has progressed after treatment with one chemotherapy regimen. Please refer
to the Eligibility Criteria page for the key inclusion and exclusion criteria.
WHAT IS SATRAPLATIN:
Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based
drugs have been clinically proven to be one of the most effective classes of anticancer
therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given
orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy
against prostate cancer in a randomized trial.
RATIONALE:
There are currently no approved chemotherapy drugs for the second line treatment of
hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in
Europe, the combination of satraplatin and prednisone had superior activity compared to
prednisone alone, for the treatment of HRPC patients who had not previously been treated
with chemotherapy
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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