NRG-GU009 (Prostate Cancer)

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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Male (cisgender)
Non-binary or gender fluid
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital
Duke Raleigh Hospital
Other

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

Yes

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

William
Lee

Protocol Number

PRO00108295

NCT ID

NCT04513717

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov