Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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
Study ID: NCT04523207
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Arizona Urology Specialists, 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, 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
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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