Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

Histologically confirmed adenocarcinoma of the prostate
High-risk disease defined by a total Gleason Sum Score greater than equal to (\>=) 4+3 (=Grade Groups \[GG\] 3-5) and \>=1 of the following 4 criteria: a) Any combination of Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in \>= 6 systematic cores (with \>=1 core Gleason Score 8 \[4+4 or 5+3\] included); b) Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in \>=3 systematic cores and Prostate-specific antigen (PSA) \>=20 ng/mL (with \>= 1 core Gleason Score 8 \[4+4 or 5+3\] included); c) Gleason Score \>=9 (=GG 5) in at least 1 systematic or targeted core; d) At least 2 systematic or targeted cores with continuous Gleason Score \>=8 (=GG 4), each with \> 80 percent (%) involvement
Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Contraceptive use by male participants (and female partners of male participants enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
Able to receive androgen deprivation therapy (ADT) for at least 13 months

Criterios de exclusión

Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Participants are considered eligible only if the central radiological review confirms clinical stage M0
(a) Prior treatment with androgen receptor antagonists; (b) Treatment with gonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF) signature
History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
Use of any investigational agent less than or equals to (\<=)4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
Major surgery \<=4 weeks prior to randomization
Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary

Intervenciones

drug

Apalutamide

Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.

drug

Androgen Deprivation Therapy (ADT)

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 \[ng/dL\]).

drug

Placebo

Participants will receive matching placebo oral tablets daily.

Ubicaciones

Hospital Aleman

Caba, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma de, Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

Centro Urologico Profesor Bengio

Córdoba, Argentina

Uroclinica

Mendoza, Argentina

Clinica Mayo de UMCB

San Miguel de Tucumán, Argentina

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Apalutamide

Androgen Deprivation Therapy (ADT)

Placebo

Ubicaciones

Hospital Aleman

Hospital Italiano de Buenos Aires

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Centro Urologico Profesor Bengio

Uroclinica

Clinica Mayo de UMCB

Patrocinadores