A Phase III Study of Darolutamide versus Placebo Added to Standard Treatment in Men with Localized, Very High-Risk Prostate Cancer

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Full Title

DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801). A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer

Purpose

The standard approach to treating high-risk prostate cancer that has not spread is radiation therapy plus androgen deprivation therapy (a type of hormonal therapy) to reduce the levels of male sex hormones, which can stop prostate cancer from coming back or spreading. Researchers think that adding the study drug darolutamide to the usual approach may be a safe treatment that could work better than the standard alone to reduce the risk of cancer recurrence in men with localized high-risk prostate cancer.

Darolutamide blocks androgen hormones (another type of male sex hormone) and can slow or stop the growth of prostate cancer cells. Patients in this study will be randomly assigned to receive radiation therapy and hormonal therapy with darolutamide or a placebo. The medications used in this study are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have localized or biochemically recurrent high-risk prostate cancer that has not yet been treated with radiation therapy. 
  • Patients may have started standard androgen deprivation therapy (such as Degarelix, Lupron, or bicalutamide) but can only have been on it for less than 3 months.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for men age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Sean McBride at 646-608-2450.

Protocol

20-547

Phase

III

Investigator

Co-Investigators