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A Single Arm, Phase I/II Trial of Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men with Localized, High Risk Prostate Cancer (BTCRC-GU19-404) (PSCI# 21-195)
The purpose of this study is to estimate the efficacy of neoadjuvant androgen deprivation, darolutamide, and ipatasertib in men with previously untreated, localized, high-risk prostate cancer that is lacking PTEN, as measured by the pathological complete response or minimal residual disease. This exact combination of drugs has not been tested in people. However, human studies combining ipatasertib with similar drugs called abiraterone or enzalutamide were found to be safe. Part One of this study tested the safety of combining these three drugs. If that dose is found to be safe in participants, the study will move to the second part. The purpose of Part Two is to answer the following question: can combining a drug called ipatasertib with androgen deprivation therapy (ADT) and a drug called darolutamide for 6 months before surgery cause prostate cancer tumors to completely resolve or almost resolve?
Male
18 year(s) or older
NCT04737109
Cancer