A Phase 1b/2 Study of Copanlisib Plus Degarelix in People With Prostate Cancer

Share

Full Title

CHARIOT: A Phase 1b/2 Study of Androgen Deprivation Therapy and Copanlisib in High-Risk Localized Prostate Cancer Patients Prior to Radical Prostatectomy

Purpose

Standard treatments for prostate cancer include degarelix and other drugs that work by blocking the activity of hormone receptors. Researchers have found that this can cause cancer cells to send more growth signals in cancers with changes in a gene called PTEN. Copanlisib may help prevent the growth of prostate cancer with a loss of PTEN function when given with degarelix.

In this study, researchers want to find the highest dose of copanlisib when given with degarelix before prostate cancer surgery. The people in this study have prostate cancer that has not spread and can be treated with surgery. In addition, their cancers have PTEN changes.

Copanlisib is given intravenously (by vein). Degarelix is given as an injection under the skin.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have prostate cancer that has not spread and will be treated with surgery.
  • Have prostate cancer that is considered high-risk and has a loss of PTEN function.
  • Not have had prior radiation therapy to the prostate.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Dana Rathkopf’s office at 646-422-4379.

Protocol

23-331

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06218667