Clinical Trial of Androgen Deprivation Therapy and Copanlisib in High-Risk Prostate Cancer Patients with PTEN Loss Prior to Radical Prostatectomy

Summary: 

Prostate cancer is the most common cancer in men and is the second leading cause of cancer death in men. It is characterized by dependence on the androgen receptor and activation of PI3K signaling pathway when the tumor suppressor gene, PTEN, is lost. Despite surgical removal of the prostate and initial responses to treatment of prostate cancer with drugs that target the androgen receptor, such as degarelix, it is rarely curative due to the presence of resistant cells at the time therapy is initiated. Copanlisib is a newer drug that targets the PI3K pathway. This phase I/II study will assess the safety and effectiveness of copanlisib in combination with degarelix in patients with high-risk localized prostate cancer with PTEN loss prior to surgery.

Trial Registration: ClinicalTrials.gov Identifier: NCT06218667