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Clinical Trials in the UK / NCT03767244
Active, not recruiting Phase 3

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

NCT03767244 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2019-06-11
Last updated
2026-08-28

Condition(s) studied

Prostatic Neoplasms

Investigational drug(s) / intervention(s)

ApalutamideAndrogen Deprivation Therapy (ADT)Placebo

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)

Trial sites (203)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT03767244 on ClinicalTrials.gov ↗ ← All trials in the UK