NRG-GU008 Prostate Cancer

What is the Purpose of this Study?

We are doing this study to find out if an investigational drug called apalutamide (the study drug) is a safe and effective treatment for your form of cancer. We want to know how well people respond to the usual therapy (hormone therapy and radiation) in combination with the study drug compared to the usual therapy on its own.

What is the Condition Being Studied?

Node-Positive Prostate Cancer after Radical Prostatectomy

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with prostate adenocarcinoma
  • Have pathologically node positive disease with nodal involvement only in the pelvis in the

prostatectomy specimen

For more information about who can join this study, please contact the study team at brant.inman@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:

  • One group will get the standard hormone drugs for up to 24 months plus radiation therapy for 5-8 weeks
  • The other group will get the standard hormone drugs for up to 24 months, radiation therapy for 5-8 weeks, and the study drug for 24 months

Study Details

Full Title
NRG-GU008, Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging into Salvage Treatment for Patients with Node-Positive Prostate Cancer after Radical Prostatectomy (INNOVATE*)
Principal Investigator
Professor of Radiation Oncology
Protocol Number
IRB: PRO00112257
NCT: NCT04134260
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL