A Phase III Study of Hormonal Therapy with Apalutamide or a Placebo in Men with High-Risk Localized or Locally Advanced Prostate Cancer Before Prostate Removal Surgery

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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 (WIRB)

Purpose

The purpose of this study is to see if apalutamide plus hormonal therapy is safe and could improve the results of surgery and delay the time to when prostate cancer spreads to other parts of the body. This treatment is being evaluated in men with high-risk localized and locally advanced prostate cancer who are planning to have radical prostatectomy (surgical removal of the whole prostate and surrounding tissue). Apalutamide and hormonal therapy are approved to treat patients with prostate cancer; their use together before prostatectomy is considered investigational.

Patients in this study will be randomly assigned to receive hormonal therapy with or without apalutamide before prostatectomy to shrink the cancer and hopefully make the surgery more effective, and then again after the surgery to reduce the chance that the prostate cancer will come back. Apalutamide is taken orally (by mouth) and hormonal therapy is given via injection.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have high-risk localized or locally advanced prostate cancer and be planning to have radical prostatectomy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for men age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Deaglan McHugh at 631-212-6320.

Protocol

20-184

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators