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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 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Apalutamide
  • DRUG Androgen Deprivation Therapy (ADT)

Study Locations (20)

California

  • UC San Diego Moores Cancer Center — La Jolla
  • University of Southern California — Los Angeles
  • Cedars Sinai Medical Center — Los Angeles
  • University of California Los Angeles — Los Angeles
  • University of California Irvine Medical Center Chao Family Comprehensive Cancer Center — Orange
  • UC Davis Medical Center — Sacramento

Florida

  • Urology Specialists LLC — Hialeah
  • Mayo Clinic - Division Of Hematology/oncology — Jacksonville
  • Miami Cancer Institute at Baptist Health / Baptist Health Medical Group — Miami
  • Advent Health — Orlando

Colorado

  • AdventHealth Medical Group Urology of Denver — Denver
  • Colorado Clinical Research — Lakewood

Massachusetts

  • Dana Farber Cancer Institute — Boston
  • Beth Isreal Deaconess Medical Center — Boston

Connecticut

  • Stamford Hospital — Stamford

Georgia

  • Emory University Winship Cancer Institute — Atlanta

Illinois

  • University of Chicago — Chicago

Louisiana

  • Ochsner LSU Health Shreveport - Regional Urology — Shreveport

Trial Details

FieldValue
Enrollment Target 2,517 participants
Start Date 2019-06-11
Est. Completion 2028-10-13
Phase Phase 3

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03767244

The ClinicalTrials.gov registry entry for NCT03767244 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,517 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03767244 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03767244 about?

NCT03767244 is a clinical study titled "A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy". 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 ...

What is the current status of trial NCT03767244?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2,517 participants. The study started on 2019-06-11. Estimated completion is 2028-10-13.

What conditions does trial NCT03767244 study?

This clinical trial studies the following conditions: Prostatic Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03767244?

The interventions under investigation include: Placebo (DRUG), Apalutamide (DRUG), Androgen Deprivation Therapy (ADT) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03767244?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03767244 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial