Precision Neoadjuvant Therapy for High Risk Localized Prostate Cancer With PTEN Loss
VA Office of Research and Development
Summary
The purpose of this study is to learn about how an investigational drug intervention completed before doing prostate surgery (specifically, radical prostatectomy with lymph node dissection) may help in treatment of high risk localized prostate cancers that are most resistant to standard treatments. This is a phase II research study. For this study, capivasertib, the study drug, will be taken with intensified androgen deprivation drugs (iADT; abiraterone and leuprolide) prior to radical prostatectomy. This study drug treatment will be evaluated to see if it is effective in shrinking and destroying prostate cancer tumors prior to surgery and to further evaluate its safety prior to prostate cancer surgery.
Description
Prostate cancer is the second leading cause of cancer deaths in men in the United States. Prostate cancer treatment options are historically based on clinical stage, prostate specific antigen (PSA) blood test, and tumor grade. High-risk prostate cancers treated surgically commonly exhibit loss of the phosphatase and tensin homologue (PTEN) tumor suppressor gene, which leads to increased activity of the AKT signaling pathway. PTEN loss is associated with higher rates of prostate cancer recurrence, metastasis, and cancer mortality. Manipulation of androgens and androgen receptor (AR) to reduce m…