Current Research: Medical Oncology

S0421 -- Docetaxel + Atrasentan Vs Docetaxel + Placebo for Advanced Hormone Refractory Prostate Cancer

The co-primary objectives are to compare survival and progression-free survival in patients with hormone refractory metastatic prostate cancer involving bone (with or without soft tissue disease) randomized between atrasentan versus placebo, combined with docetaxel and prednisone.

Eligibility

You may be eligible for this trial if:

• You have metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy by one or more of the following, assessed within 28 days prior to registration:
  • Progression of measurable disease
  • Progression of non-measurable disease
  • Rising PSA, defined as at least 2 consecutive rises in PSA
• You must have been surgically/medically castrated
• It has been at least 21 days since completion of ANY surgery and you have recovered from all side effects
• You have been treated with: ketoconazole treatment, it must have been stopped 14 days prior to registration; flutamide, bicalutamide or nilutamide treatment must have been stopped 28 days prior to registration
• Prior radiation therapy (samarium, not strontium) is allowed; treatment must have been completed 21 days prior to registration.

Trial Sponsor

• Southwest Oncology Group (SWOG)

Project Begin Date

• Mar 2009

Tentative Project End Date

• Sept 2012

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .