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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00069745

Enrollment

Unknown

Registered

2003-10-06

Start date

2003-09-30

Completion date

2007-03-31

Last updated

2012-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone Refractory Prostate Cancer, Prostate Cancer

Keywords

Prostatic Neoplasms, Cancer Treatment Protocols, Antineoplastic protocols, One Prior Cytotoxic Chemotherapy Regimen

Brief summary

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

Interventions

DRUGSatraplatin

DRUGPrednisone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Countries

Argentina, Belgium, Croatia, France, Germany, Hungary, Israel, Italy, Netherlands, Peru, Poland, Russia, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026