A Phase 3 Study of Apalutamide With Androgen-Deprivation Therapy in People With Advanced Prostate Cancer


Full Title

A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide with Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) following PSA Response in Participants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)


Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the best treatments for prostate cancers that have metastasized (spread). The benefits of hormone treatments do not last, however. Over time, many prostate cancers keep growing even with hormonal therapies. These are called castration-resistant prostate cancers (CRPC).

Apalutamide plus standard androgen-deprivation therapy (ADT) may help people with metastatic CRPC (mCRPC). ADT is a standard hormonal treatment for people with mCRPC. Researchers in this study are assessing apalutamide plus short-term ADT followed by apalutamide alone. They want to learn if this treatment works as well for shrinking the cancer and preventing it from getting worse. They also hope it causes fewer side effects compared to apalutamide with ADT given constantly (continuously).

If you join this study, you will be randomly assigned to get one of these treatments:

  • Apalutamide alone. You can restart ADT if your disease gets worse.
  • Apalutamide plus standard ADT.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have mCRPC.
  • Not have had prior treatment for mCRPC, except for up to 3 months of ADT.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.


For more information and to see if you can join this study, please call Dr. Dana Rathkopf’s office at 646-422-4379.




Phase III (phase 3)

Disease Status

Newly Diagnosed & Relapsed/Refractory



ClinicalTrials.gov ID