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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

Phase 3
18 Years
Not Enrolling
Prostate Cancer, Hormone Refractory Prostate Cancer

Thank you

Trial Information

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

Inclusion Criteria:

- Stage D2 metastatic prostate cancer

- Progression after one prior chemotherapy

- ECOG Performance status equal / less than 2

- Life expectancy > 3 months

- Surgical or medical castration

- Adequate bone marrow, hepatic and renal functions

- Informed consent

Exclusion Criteria:

- More than one prior chemotherapy

- Prior platinum containing compounds

- Prior malignancy

- Prior significant RT/radionuclide therapy

- Major GI surgery or GI disease affecting absorption

- Disease with contraindication to steroids

- Brain metastases

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:

GPC SAT3-03-01



Start Date:

September 2003

Completion Date:

March 2007

Related Keywords:

  • Prostate Cancer
  • Hormone Refractory Prostate Cancer
  • Prostatic Neoplasms
  • Cancer Treatment Protocols
  • Antineoplastic protocols
  • One Prior Cytotoxic Chemotherapy Regimen
  • Prostatic Neoplasms



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