A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 South Korea
Other trials for the same condition
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 South Korea