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COMPLETED
NCT04523207
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Apalutamide

Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) oral tablets during the main study and sub-study.

DRUG

ADT

Participants will receive ADT intramuscular or subcutaneously during the main study.

DRUG

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