A Phase III clinical trial of Sprycel + Taxotere in CRPC

Bristol-Myers Squibb has announced the launch of the READY Phase III trial designed to compare dasatinib (Sprycel) + docetaxel (Taxotere) + prednisone as first-line chemotherapy compared to placebo + docetaxel + prednisone in men with metastatic castration-resistant prostate cancer (CRPC).

There are currently 180 sites at which it will be possible to enroll in this trial — in the USA and in many other countries too. Full details of this trial can be found on the ClinicalTrials.gov web site. The primary endpoint is overall survival.

To be eligible for the trial, patients must have:

  • A histological diagnosis of prostate cancer
  • Clear evidence of metastatic disease
  • Clear evidence of progression, by rising PSA, nodal/visceral disease, bone scan, or local recurrence
  • A serum testosterone ≤ 50 ng/dl
  • The ability to take oral medications
  • A performance status 0 or 1

You will not be eligible to participate in this trial if you have one or more of the following:

  • Active brain or leptomeningeal metastases
  • Clinically significant cardiovascular disease
  • Pleural or pericardial effusion
  • A currently active second malignancy
  • Any uncontrolled intercurrent illness
  • Prior cytotoxic chemotherapy, with the sole exception of estramustine

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