NRG-GU008 Prostate Cancer

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:<ul>
<li>Are diagnosed with prostate adenocarcinoma</li>
<li>Have pathologically node positive disease with nodal involvement only in the pelvis in the
prostatectomy specimen</li></ul>
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:<ul>
<li>One group will get the standard hormone drugs for up to 24 months plus radiation therapy for 5-8 weeks</li>
<li>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</li></ul>

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 Enrollment