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

PHASE2CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

August 19, 2020

Primary Completion Date

October 23, 2023

Study Completion Date

October 25, 2023

Conditions
Prostatic Neoplasms
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.

Trial Locations (32)

13210

Associated Medical Professionals, Syracuse

14225

Great Lakes Physician PC d/b/a Western New York Urology Associates, Cheektowaga

17604

Lancaster Urology, Lancaster

19004

MidLantic Urology, Bala-Cynwyd

20169

Lexington Urology, West Columbia

23235

Virginia Urology, Richmond

23462

Urology Of Virginia, Pllc, Virginia Beach

27612

Associated Urologists of North Carolina, Raleigh

29572

Carolina Urologic Research Center, Myrtle Beach

33016

Urological Research Network, Hialeah

37209

Urology Associates, Nashville

45212

The Urology Group, Cincinnati

47130

First Urology, PSC, Jeffersonville

48084

Michigan Institute of Urology, PC, Troy

50266

The Iowa Clinic, West Des Moines

67226

Wichita Urology Group, Wichita

68114

Adult Pediatric Urology & Urogynecology, P.C, Omaha

71106

Ochsner LSU Health Shreveport - Regional Urology, Shreveport

72211

Arkansas Urology, Little Rock

77027

Houston Metro Urology, Houston

78229

Urology San Antonio Research, San Antonio

78745

Urology Austin, Austin

80211

The Urology Center of Colorado, Denver

80228

Foothills Urology - Golden Off, Lakewood

83642

Idaho Urologic Institute, Meridian

85704

Arizona Urology Specialists, Tucson

85741

Arizona Urology Specialists, Tucson

90505

Genesis Research, Torrance

91411

Skyline Urology, Sherman Oaks

97477

Oregon Urology Institute, Springfield

99202

Spokane Urology, Spokane

08043

New Jersey Urology LLC, Voorhees Township

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT04523207 - 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 | Biotech Hunter | Biotech Hunter