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.
Who Can Participate?
Eligibility
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.
- 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 Range
18-100
Sex/Genders
Male (cisgender)
Transgender female
Looking for Healthy Participants
No
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
- 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
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
William
Lee
Protocol Number
PRO00112257
NCT ID
NCT04134260
Phase
III
Enrollment Status
OPEN TO ACCRUAL