Lay Title: A Study for Men with Prostate Cancer who are Candidates for Radical Prostatectomy
Technical 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
Disease Type: High-risk prostate cancer that is localized or locally advanced
Basic information: The purpose of this study is to see if the study drug, apalutamide, plus androgen deprivation therapy (ADT, also known as hormone therapy) is safe; if it can improve the results of radical prostatectomy (surgery to remove the prostate and surrounding tissue); and if it delays the spread of prostate cancer to other parts of the body.
Participants will be randomized to be in one of two treatment groups:
Group 1: ADT + placebo
Group 2: ADT + study drug (apalutamide)
ADT is not routinely given to patients before RP and has not been proven to work. It is, however, routinely given to patients after RP.
Research Procedures (not a complete list):
The study is divided into 3 parts:
Part 1 (6 months): Treatment with ADT with or without apalutamide before radical prostatectomy. The aim is to reduce the size of the prostate to make surgery more effective.
Part 2: Radical prostatectomy, which is performed as part of your usual care.
Part 3: Resume treatment with ADT with or without study drug. The aim is to reduce the chance that prostate cancer could come back.
You will need to come to the clinic once a month while you are on the study. Depending on the visits, you will undergo assessments such as physical exam, lab draws, ECG, and be asked to complete questionnaires.
Eligibility Criteria (not a complete list):
For More Detailed Information, Contact:
Read more about this study (NCT03767244) on ClinicalTrials.gov.