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NCT03767244 · ClinicalTrials.gov registry record · Phase 3
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
A Phase 3 study of Prostatic Neoplasms, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 2,517
- Enrollment target
- 20
- Study locations
NCT03767244 is a Phase 3 study of Prostatic Neoplasms that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 2,517 participants, above the 476-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (429% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT03767244, a Phase 3 study of Prostatic Neoplasms, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,517 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 2,517 participants |
| Start Date | 2019-06-11 |
| Est. Completion | 2028-10-13 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 2,517 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 476-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (429% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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.
NCT03767244 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Colorado.
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.
What interventions are being tested in trial NCT03767244?
The interventions under investigation include: Placebo (DRUG), Apalutamide (DRUG), Androgen Deprivation Therapy (ADT) (DRUG).
Who is sponsoring clinical trial NCT03767244?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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.
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