Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Prostate Cancer, Hormone Refractory Prostate Cancer

Intervention / Treatment
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* Drug: Satraplatin
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Satraplatin|nan|
|Drug: Prednisone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic Neoplasms, Cancer Treatment Protocols, Antineoplastic protocols, One Prior Cytotoxic Chemotherapy Regimen