Propella: Intramuscular abiraterone decanoate for metastatic prostate cancer

Purpose of this Study

We are doing this study to find out if an investigational drug called PRL-02 (the study drug) is a safe and effective method to lower levels of male hormones during treatment for prostate cancer. The study drug is an injectable form of a drug called abiraterone.

Who Can Participate?

Eligibility

Adults ages 18+ who: For more information about who can join this study, please contact the study team at julia.hurrelbrink@duke.edu.

What is Involved?

Description

If you choose to join this study, you will:
  • Get the study drug as an injection into one of your muscles about every 12 weeks
  • Have blood draws and give urine samples
  • Have imaging done (CT or MRI and bone scans)
  • Have heart scans (ECG)
  • Have breathing tests
You may or may not take steroid medications (prednisone or dexamethasone) during the study. Whether or not you are assigned to take steroids while you get the study drug will depend on when you join the study. The dose of study drug you take will also depend on when you join the study. You will take the study drug for as long as you and your doctor believe that you are benefitting. When you finish taking the study drug, we might ask you to have an ACTH stimulation test. This test involves an injection and 2 blood draws to make sure that your adrenal glands are working properly.

Study Details

Full Title

Phase 1/2a, Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients with Advanced Prostate Cancer (PRL-02-1001)

Principal Investigator

Michael
Harrison

Protocol Number

PRO00109059

NCT ID

NCT04729114

Phase

I/II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov