A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Active:	No
Cancer Type:	Prostate Cancer Unknown Primary	NCT ID:	NCT03767244
Trial Phases:	Phase III	Protocol IDs:	CR108535 (primary) 56021927PCR3011 2018-001746-34 NCI-2019-04921 2018-001746-34
Eligibility:	18 Years and older, Male	Study Type:	Treatment
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT03767244

Summary

The purpose of this study is to determine if treatment with apalutamide plus androgen
deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph
node dissection (pLND) 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 placebo plus ADT.

Objectives

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 RP with pLND. It is hypothesized that
androgen blockade prior to and after RP with pLND 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 RP with pLND 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 (the planned Treatment Phase will include a
total of 12 treatment cycles of apalutamide or placebo; 6 cycles prior to RP with pLND (Cycle
1 through Cycle 6) and 6 cycles after RP with pLND (Cycle 7 through Cycle 12). Cycle 1 Day 1
will start within 3 days after randomization) 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. An open-label sub-study
comparing apalutamide plus ADT before and after RP with pLND with standard of care treatment
will be initiated at selected sites upon notification by the sponsor.

Treatment Sites in Georgia

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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