Apalutamide: Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
Androgen Deprivation Therapy (ADT): Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter \[ng/dL\]).
Placebo: Participants will receive matching placebo oral tablets daily.
Study 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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate
* High-risk disease defined by a total Gleason Sum Score greater than equal to (\>=) 4+3 (=Grade Groups \[GG\] 3-5) and \>=1 of the following 4 criteria: a) Any combination of Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in \>= 6 systematic cores (with \>=1 core Gleason Score 8 \[4+4 or 5+3\] included); b) Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in \>=3 systematic cores and Prostate-specific antigen (PSA) \>=20 ng/mL (with \>= 1 core Gleason Score 8 \[4+4 or 5+3\] included); c) Gleason Score \>=9 (=GG 5) in at least 1 systematic or targeted core; d) At least 2 systematic or targeted cores with continuous Gleason Score \>=8 (=GG 4), each with \> 80 percent (%) involvement
* Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Contraceptive use by male participants (and female partners of male participants enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
* Able to receive androgen deprivation therapy (ADT) for at least 13 months
Exclusion Criteria:
* Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Participants are considered eligible only if the central radiological review confirms clinical stage M0
* (a) Prior treatment with androgen receptor antagonists; (b) Treatment with gonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF) signature
* History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
* Use of any investigational agent less than or equals to (\<=)4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
* Major surgery \<=4 weeks prior to randomization
* Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
Primary outcome measure(s)
Percentage of Participants with Pathologic complete response (pCR) — Approximately 4 years pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter.
Metastasis-Free Survival (MFS) — Up to 7 years and 5 months MFS is defined as the time from randomization to the date of the occurrence of radiographic distant metastasis evaluated by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
Trial sites (203)
Facility
City
Region
Status
UC San Diego Moores Cancer Center
La Jolla
California
University of Southern California
Los Angeles
California
Cedars Sinai Medical Center
Los Angeles
California
University of California Los Angeles
Los Angeles
California
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
Orange
California
UC Davis Medical Center
Sacramento
California
AdventHealth Medical Group Urology of Denver
Denver
Colorado
Colorado Clinical Research
Lakewood
Colorado
Stamford Hospital
Stamford
Connecticut
Urology Specialists LLC
Hialeah
Florida
Mayo Clinic - Division Of Hematology/oncology
Jacksonville
Florida
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
Miami
Florida
Advent Health
Orlando
Florida
Emory University Winship Cancer Institute
Atlanta
Georgia
University of Chicago
Chicago
Illinois
Ochsner LSU Health Shreveport - Regional Urology
Shreveport
Louisiana
Dana Farber Cancer Institute
Boston
Massachusetts
Beth Isreal Deaconess Medical Center
Boston
Massachusetts
Michigan Institute of Urology, PC
Troy
Michigan
Saint Louis University
St Louis
Missouri
Urology Cancer Center, PC
Omaha
Nebraska
Albany Medical College
Albany
New York
Great Lakes Physician PC d/b/a Western New York Urology Associates
Cheektowaga
New York
Memorial Sloan-Kettering Cancer Center
New York
New York
Weill Cornell Medical College
New York
New York
SUNY Upstate Medical University
Syracuse
New York
University of North Carolina
Chapel Hill
North Carolina
Duke University School of Medicine
Durham
North Carolina
Medication Management LLC
Greensboro
North Carolina
Carolina Urology Partners, PLLC
Huntersville
North Carolina
Cleveland VA Medical Center
Cleveland
Ohio
Oklahoma City VAMC
Oklahoma City
Oklahoma
MidLantic Urology
Bala-Cynwyd
Pennsylvania
Omega Medical Research
Warwick
Rhode Island
Ralph H. Johnson Veterans Affairs Medical Center
Charleston
South Carolina
Medical University of South Carolina
Charleston
South Carolina
Greenville Health
Greenville
South Carolina
Carolina Urologic Research Center
Myrtle Beach
South Carolina
Vanderbilt University Medical Center
Nashville
Tennessee
VA North Texas Health Care System
Dallas
Texas
+ 163 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.