NRG-GU009 (Prostate Cancer)
What is the Purpose of this Study?
We are doing this study to find out if 2 experimental treatments for high risk prostate cancer are effective compared to the usual treatments. For people with this form of cancer who also have a low gene risk score, we want to know if a short course of hormone treatment is as effective as the usual 24-month treatment. For people with a high gene risk score who will receive radiation, we want to know if adding a drug called apalutamide (study drug) to the usual treatment helps to slow the cancer's spread.
High Risk Prostate Cancer
Who Can Participate in the Study?
Adults ages 18+ who are diagnosed with high risk prostate cancer.
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.
What is Involved?
If you choose to join this study, we will:
- Take a sample of your prostate tumor tissue (biopsy)
- Test this sample for certain genes that predict the risk that your cancer will spread
- Give you a high risk or a low risk score based on the results of this test
If you get a high risk score, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- One group will get the usual hormone drugs for up to 24 months plus the usual radiation therapy for 2-11 weeks
- The other group will get the usual hormone drugs in combination with the study drug for up to 24 months plus the usual radiation therapy for 2-11 weeks
If you get a low risk score, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- One group will get the usual hormone drugs for up to 24 months plus the usual radiation therapy for 2-11 weeks
depending on the type of radiation therapy given by your doctor - The other group will get the usual hormone therapy drugs for up to 12 months plus the usual radiation therapy for 2-11 weeks
After you finish treatment, your study doctor will continue to follow your condition and watch you for side effects.