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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?
psci-cto@pennstatehealth.psu.edu
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04737109
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Inclusion Criteria:
Patient has histologically-confirmed diagnosis of localized, untreated prostate cancer with high-risk features
Patient has sufficient archival tissue (at least 2 cores) available for targeted sequencing and immunohistochemistry
Patient has measurable PSA
Patient must be male and >= 18 years of age
Patient must be able to swallow pills
Exclusion Criteria:
Patient has histology of small cell carcinoma prostate cancer. Adenocarcinoma with neuroendocrine features is allowed.
Patient has active infection requiring IV antibiotics
Patient has known additional malignancy that has a life expectancy < 10 years
Patient has distant metastatic disease beyond N1 (regional) lymph nodes on conventional baseline imaging studies within 90 days prior to signing consent
Cancer
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Location
Hershey, PA