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Trial Information for Physicians

Trial Information
Dasatinib, a multi-kinase inhibitor, is being evaluated for clinical benefit in patients with prostate cancer. The READY Trial is comparing the effects of dasatinib when added to a standard of care regimen of docetaxel and prednisone in 1,380 patients with metastatic castration-resistant prostate cancer (CRPC).

Title
A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer

Purpose
The purpose of this study is to determine whether overall survival can be prolonged in patients with metastatic CRPC who receive dasatinib in addition to a standard of care regimen of docetaxel and prednisone.

Primary Outcome:

  • Overall survival

Secondary Outcomes:

  • Rate of change from baseline in urinary N-telopeptide
  • Time to first skeletal related event
  • Rate of change from baseline in pain intensity
  • Time to prostate specific antigen (PSA) progression
  • Safety and tolerability

Exploratory:

  • Rate of objective tumor response by modified RECIST criteria (for subjects with measurable disease at baseline)
  • Rate of stable disease by bone scan/imaging at 24 weeks

Key Inclusion Criteria:

  • Histologically diagnosed metastatic prostate cancer
  • Evidence of metastatic disease (by either CT, MRI, bone scan or skeletal survey)
  • Evidence of progression (by either rising PSA, nodal/visceral disease, bone scan/imaging, or local recurrence in the prostate or prostate bed)
  • Maintenance of serum testosterone < 50 ng/dL
  • ECOG Performance Status 0, 1, or 2

Key Exclusion Criteria:

  • Prior or ongoing cytotoxic chemotherapy in the metastatic setting, with the exception of estramustine
  • Currently experiencing pleural or pericardial effusion
  • Clinically significant cardiovascular disease
  • Symptomatic brain or leptomeningeal metastases
  • Currently active second malignancy

To learn how to refer your patients to the READY clinical trial, contact the trial site near you. Please tell your patients who you feel may be eligible to participate about this clinical trial. All interested patients will be assessed for trial eligibility.

This trial is listed as trial NCT00744497 on clinicaltrials.gov.

To see if there is a Clinical Trial Site near you, click here.