Final publication of data from the ASCENT-2 clinical trial

The final report of the result of the ASCENT-2 trial has been published on line in the Journal of Clinical Oncology. The data from this study have been widely reported in the past. The addition of high-dose calcitriol (DN-101) to docetaxel-based chemotherapy in the treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) did not have a beneficial impact on patient survival.

In the final publication, Scher et al. report that:

  • Average (median) overall survival (OS) in the ASCENT arm of the trial was 17.8 months.
  • Median OS in the docetaxel-based chemotherapy arm of the trial was 20.2 months.
  • The patients in the two arms of the trial had similar rates of total and serious adverse events.
  • The most frequent of these adverse events were gastrointestinal problems (in 75 percent of patients) and blood and lymphatic disorders (in 48 percent).
  • Patients in the ASCENT arm of the trial were about twice as likely to experience docetaxel toxicity leading to dose modification (31 percent in the ASCENT arm compared to 15 percent in the docetaxel-based chemotherapy arm).

There have been a number of suggestions as to why this trial had a negative result, including the ideas that it was based on weekly dosing of docetaxel (as opposed to every 3 weeks) and that the chemical formulation of calcitriol used in this study may not have been the best candidate.

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