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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Prostatic Neoplasms

In brief

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.

Key facts

Study ID

NCT03767244

Run by

Janssen Research & Development, LLC

People needed

2517

Starts

2019-06-11

Expected to finish

2028-10-13

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Southern California — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of California Irvine Medical Center Chao Family Comprehensive Cancer Center — Orange, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• AdventHealth Medical Group Urology of Denver — Denver, Colorado, United States
• Colorado Clinical Research — Lakewood, Colorado, United States
• Stamford Hospital — Stamford, Connecticut, United States
• Urology Specialists LLC — Hialeah, Florida, United States
• Mayo Clinic - Division Of Hematology/oncology — Jacksonville, Florida, United States
• Miami Cancer Institute at Baptist Health / Baptist Health Medical Group — Miami, Florida, United States
• Advent Health — Orlando, Florida, United States
• Emory University Winship Cancer Institute — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Ochsner LSU Health Shreveport - Regional Urology — Shreveport, Louisiana, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Isreal Deaconess Medical Center — Boston, Massachusetts, United States
• Michigan Institute of Urology, PC — Troy, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• Urology Cancer Center, PC — Omaha, Nebraska, United States
• Albany Medical College — Albany, New York, United States
• Great Lakes Physician PC d/b/a Western New York Urology Associates — Cheektowaga, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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