Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer
Status:
Recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
Summary
This multicenter Phase I/II trial consists of two stages: a phase I stage in patients with
castration resistant prostate cancer in which the recommended phase II dose will be
determined for ipatasertib administered in combination with darolutamide; and a phase II
neoadjuvant stage in which patients with high risk prostate cancer and loss of PTEN
expression in the tumor tissue planning on undergoing prostatectomy receive ADT,
darolutamide, and ipatasertib for 24 weeks prior to planned surgery.