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Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA)

Phase 3
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA)

*****UPDATE***** On October 30th, 2007 GPC Biotech announced topline overall survival
results for the Phase III trial in hormone refractory prostate cancer-Satraplatin and
Prednisone Against Refractory Cancer (SPARC) trial.

The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a
second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The
companies reported that the trial did not achieve the endpoint of overall survival (p=0.80,
stratified log rank analysis). The median was 61.3 weeks for the satraplatin arm compared
to 61.4 weeks for the control group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13). The
companies are currently conducting pre-specified subset analyses.

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

Inclusion Criteria:

- Metastatic(Stage D2)prostate cancer

- Progression after unlimited prior cytotoxic chemotherapy regimens

- ECOG Performance status equal/less than 2

- Surgical or medical castration

- Adequate bone marrow, liver, and renal function

- Informed consent

- Patients treated with bisphosphonates prior to entry are eligible and should
continue bisphosphonates therapy while on this trial

Exclusion Criteria:

- Serious concurrent uncontrolled medical disorder

- Malignant disease requiring on-going therapy

- Prior significant RT/radionuclide therapy

- Major GI surgery or GI disease affecting absorption

- Disease where corticosteroids are contraindicated

- Brain metastases

- Poorly-controlled or uncontrolled insulin-dependent diabetes

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The SPERA trial is designed to provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited prior cytotoxic chemotherapy regimens for metastatic disease.

Outcome Time Frame:

Patient evaluation by MD at baseline to determine eligibility.

Safety Issue:


Principal Investigator

Philippe Pultar, MD

Investigator Role:

Study Director

Investigator Affiliation:

GPC Biotech Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

December 2009

Related Keywords:

  • Prostate Cancer
  • Hormone Refractory Prostate Cancer (HRPC)
  • Hormone Refractory Prostate Cancer
  • Unlimited Prior Cytotoxic Chemotherapy Regimens
  • Prostatic Neoplasms



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