Apalutamide in Advanced Prostate Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if a drug called apalutamide, given in combination with androgen deprivation therapy (ADT), also known as hormone therapy, is safe and could improve outcomes after surgery or delay the time to cancer progression.

What is the Condition Being Studied?

Prostate Cancer

Who Can Participate in the Study?

Men, 18+ who:
- Have high-risk prostate cancer
- Have total Gleason Sum Score greater than or equal to 4+3
- Are candidates for radical prostatectomy with pelvic lymph node dissection
- Do not have any other health conditions that may risk your ability to participate in the study

Age Group

What is Involved?

If you choose to join this study, you will:
-Be randomly assigned to Group 1 or Group 2:
--Group 1 will get the study drug (apalutamide) plus Androgen Deprivation Therapy (ADT)
--Group 2 will get a placebo (harmless, inactive

Both groups will:
-Get the study drug or placebo for about 6 months before your radical prostatectomy and 6 months after your radical prostatectomy
-Complete approximately 12 study visits
-Have follow-up for 3-4 years

Study Details

Full Title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy
Principal Investigator
Urologic Oncologist
Protocol Number
IRB: PRO00105407
NCT: NCT03767244
Phase III
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center