NRG-GU009 (Prostate Cancer) - Clinical Trial

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.

What is the Condition Being Studied?

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.

Age Group
Adults

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:
- Be randomly assigned (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:
- Be randomly assigned (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.

Study Details

Full Title
Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation (PREDICT-RT*)
Principal Investigator
Radiation Oncologist
Protocol Number
IRB: PRO00108295
NCT: NCT04513717
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698