A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Part of paid clinical trials in La Jolla, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03767244
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
  • Androgen Deprivation Therapy (ADT) — DRUG
    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 — DRUG
    Participants will receive matching placebo oral tablets daily.

Study Details

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.

Key Dates

Start date
Jun 11, 2019
Status verified
Jun 2026
Primary completion
Dec 1, 2026
Completion
Oct 13, 2028

Study Design

Enrollment
2,517 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apalutamide + ADT
    Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment. A Long-Term Extension (LTE) may be initiated at sponsor's discretion after completion of the primary endpoint analysis.
  • Experimental: Placebo + ADT
    Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment. A LTE may be initiated at sponsor's discretion after completion of the primary endpoint analysis.

Primary Outcome Measure

Percentage of Participants with Pathologic complete response (pCR) [ Time Frame: Approximately 4 years ]

Locations (44)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
University of California Los AngelesLos AngelesCalifornia90095-
University of Southern CaliforniaLos AngelesCalifornia90033-
University of California Irvine Medical Center Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
UC Davis Medical CenterSacramentoCalifornia95817-
AdventHealth Medical Group Urology of DenverDenverColorado80210-
Colorado Clinical ResearchLakewoodColorado80228-
Stamford HospitalStamfordConnecticut06904-
Urology Specialists LLCHialeahFlorida33002-
Mayo Clinic - Division Of Hematology/oncologyJacksonvilleFlorida32224-
Miami Cancer Institute at Baptist Health / Baptist Health Medical GroupMiamiFlorida33176-
Advent HealthOrlandoFlorida32804-
Emory University Winship Cancer InstituteAtlantaGeorgia30322-1013-
University of ChicagoChicagoIllinois60637-
Ochsner LSU Health Shreveport - Regional UrologyShreveportLouisiana71106-
Beth Isreal Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Michigan Institute of Urology, PCTroyMichigan48084-
Saint Louis UniversitySt LouisMissouri63110-
Urology Cancer Center, PCOmahaNebraska68130-
Albany Medical CollegeAlbanyNew York12208-
Great Lakes Physician PC d/b/a Western New York Urology AssociatesCheektowagaNew York14225-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Weill Cornell Medical CollegeNew YorkNew York10065-
SUNY Upstate Medical UniversitySyracuseNew York13210-
University of North CarolinaChapel HillNorth Carolina27599-
Duke University School of MedicineDurhamNorth Carolina27705-
Medication Management LLCGreensboroNorth Carolina27403-
Carolina Urology Partners, PLLCHuntersvilleNorth Carolina28078-
Cleveland VA Medical CenterClevelandOhio44106-
Oklahoma City VAMCOklahoma CityOklahoma73104-
MidLantic UrologyBala-CynwydPennsylvania19004-
Omega Medical ResearchWarwickRhode Island02886-
Medical University of South CarolinaCharlestonSouth Carolina29403-
Ralph H. Johnson Veterans Affairs Medical CenterCharlestonSouth Carolina29401-
Greenville HealthGreenvilleSouth Carolina29605-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
Vanderbilt University Medical CenterNashvilleTennessee37232-
VA North Texas Health Care SystemDallasTexas75216-
MD Anderson Cancer CenterHoustonTexas77030-
Virginia UrologyRichmondVirginia23235-
Urology of Virginia, PLCCVirginia BeachVirginia23462-
CAMC Memorial Hospital, Charleston Area Medical Center PhysiciansCharlestonWest Virginia25304-

Find similar trials in La Jolla, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
UC San Diego Moores Cancer Center· La Jolla, CACedars Sinai Medical Center· Los Angeles, CAUniversity of California Los Angeles· Los Angeles, CAUniversity of Southern California· Los Angeles, CAUniversity of California Irvine Medical Center Chao Family Comprehensive Cancer Center· Orange, CAUC Davis Medical Center· Sacramento, CA

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