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:
- Are diagnosed with advanced prostate cancer
- Have reduced levels of male hormones due to surgery or medication
- Do not have any other cancer that requires treatment
- Do not have an allergy to abiraterone
- Have a body mass index (BMI) of 40 or less ( BMI calculator: https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm )
For more information about who can join this study, please contact the study team at julia.hurrelbrink@duke.edu.
- Are diagnosed with advanced prostate cancer
- Have reduced levels of male hormones due to surgery or medication
- Do not have any other cancer that requires treatment
- Do not have an allergy to abiraterone
- Have a body mass index (BMI) of 40 or less ( BMI calculator: https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm )
For more information about who can join this study, please contact the study team at julia.hurrelbrink@duke.edu.
What is Involved?
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.
- 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
Principal Investigator
Michael
Harrison
Protocol Number
PRO00109059
NCT ID
NCT04729114
Phase
I/II
Enrollment Status
OPEN TO ACCRUAL