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
18 Years and older, Male
The purpose of this study is to determine if treatment with androgen deprivation therapy (ADT) plus apalutamide before and after radical prostatectomy in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS), as compared to ADT plus placebo.
High-risk prostate cancer accounts for approximately 15 percent (%) of newly diagnosed
prostate cancers. A systemic therapy that eradicates micrometastatic disease is needed to
improve survival in high-risk participants undergoing radical prostatectomy. It is
hypothesized that androgen blockade prior to and after radical prostatectomy may improve
outcomes for participants at the highest risk for recurrence. This study is designed to
evaluate if androgen blockade administered prior to and after radical prostatectomy will
increase the rate of pathological complete response (pCR) and lead to better overall
outcomes. ERLEADA (apalutamide, also known as JNJ-56021927 and ARN-509) is an orally
available, non-steroidal small molecule, which acts as a potent and selective antagonist of
the androgen receptor (AR), currently being developed for the treatment of prostate cancer.
The study includes screening phase (approximately up to 35 days before randomization),
treatment phase (up to 12 months) and follow-up phase. The end of study (study completion) is
defined as last participant assessment at study site with approximate study duration of 8
years. Participants will undergo efficacy, pharmacokinetics and biomarker evaluations. The
safety will be monitored throughout the study.