Martin T. King, MD, PhD
The phase III ARAMIS trial showed that darolutamide (Nubeqa) plus androgen deprivation therapy (ADT) significantly improved overall survival (OS) compared with placebo plus ADT in patients with nonmetastatic castration-resistant prostate cancer.
Investigators for the phase II INTREPId trial (NCT04025372) are now trying to determine whether darolutamide can be successfully substituted for ADT for use in combination with radiation therapy (RT) for patients with intermediate-risk prostate cancer. The researchers hope to improve patients’ quality of life by replacing ADT, as the treatment is associated with several adverse events, including erectile dysfunction.
The INTREPId trial has a target enrollment of 220 patients who will be randomized to oral bicalutamide daily with a gonadotropin-releasing hormone agonist as prescribed and RT starting 8 to 12 weeks after ADT or oral darolutamide twice daily plus RT.
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