Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Sponsor: Janssen Research & Development, LLC
Summary
Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate. Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.
Official title: A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2020-08-19
Completion Date
2023-10-25
Last Updated
2026-04-21
Healthy Volunteers
No
Conditions
Interventions
Apalutamide
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) oral tablets during the main study and sub-study.
ADT
Participants will receive ADT intramuscular or subcutaneously during the main study.
Relugolix
Participants will receive 120 mg of relugolix following a loading dose of 360 mg of (3 tablets of 120 mg each) relugolix during the sub-study.
Locations (32)
Arizona Urology Specialists 1
Tucson, Arizona, United States
Arizona Urology Specialists
Tucson, Arizona, United States
Arkansas Urology
Little Rock, Arkansas, United States
Skyline Urology
Sherman Oaks, California, United States
Genesis Research
Torrance, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Foothills Urology - Golden Off
Lakewood, Colorado, United States
Urological Research Network
Hialeah, Florida, United States
Idaho Urologic Institute
Meridian, Idaho, United States
First Urology, PSC
Jeffersonville, Indiana, United States
The Iowa Clinic
West Des Moines, Iowa, United States
Wichita Urology Group
Wichita, Kansas, United States
Ochsner LSU Health Shreveport - Regional Urology
Shreveport, Louisiana, United States
Michigan Institute of Urology, PC
Troy, Michigan, United States
Adult Pediatric Urology & Urogynecology, P.C
Omaha, Nebraska, United States
New Jersey Urology LLC
Voorhees Township, New Jersey, United States
Great Lakes Physician PC d/b/a Western New York Urology Associates
Cheektowaga, New York, United States
Associated Medical Professionals
Syracuse, New York, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
The Urology Group
Cincinnati, Ohio, United States
Oregon Urology Institute
Springfield, Oregon, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Lancaster Urology
Lancaster, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Lexington Urology
West Columbia, South Carolina, United States
Urology Associates
Nashville, Tennessee, United States
Urology Austin
Austin, Texas, United States
Houston Metro Urology
Houston, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
Virginia Urology
Richmond, Virginia, United States
Urology Of Virginia, Pllc
Virginia Beach, Virginia, United States
Spokane Urology
Spokane, Washington, United States