The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

HRR gene alteration (as identified by the sponsor's required assays) as follows:
Cohort 1: positive for HRR gene alteration
Cohort 2: not positive for DRD (that is, HRR gene alteration)
Cohort 3: eligible by HRR status
Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (\<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy
Able to continue GnRHa during the study if not surgically castrate
Score of \<= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)

Criterios de exclusión

Prior treatment with a poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor
Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone \[AAP\] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting
Symptomatic brain metastases
History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) \<= 2 years prior to randomization, or malignancy that currently requires active systemic therapy

Intervenciones

drug

Niraparib

Participants will receive niraparib 200 mg capsules or tablets once daily.

drug

Abiraterone Acetate

Participants will receive AA 1000 mg tablets once daily.

drug

Prednisone

Participants will receive prednisone 10 mg tablets daily.

drug

Placebo

Participants will receive matching placebo once daily.

drug

New Formulation of Niraparib and Abiraterone Acetate (AA)

Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.

Ubicaciones

Hospital Aleman

Buenos Aires, Argentina

Centro Oncológico Korben

Buenos Aires, Argentina

CEMIC Saavedra

Buenos Aires, Argentina

Centro de Urologia (CDU)

Ciudad Automoma Buenos Aires, Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, Argentina

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Argentina

Hospital Privado de Comunidad

Mar del Plata, Argentina

Centro de Investigacion Pergamino SA

Pergamino, Argentina

Sanatorio Britanico de Rosario

Rosario, Argentina

Sanatorio Parque

Rosario, Argentina

ARS Médica

San Salvador de Jujuy, Argentina

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Niraparib

Abiraterone Acetate

Prednisone

Placebo

New Formulation of Niraparib and Abiraterone Acetate (AA)

Ubicaciones

Hospital Aleman

Centro Oncológico Korben

CEMIC Saavedra

Centro de Urologia (CDU)

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Hospital Privado Centro Medico de Cordoba

Instituto de Investigaciones Clinicas Mar del Plata

Hospital Privado de Comunidad

Centro de Investigacion Pergamino SA

Sanatorio Britanico de Rosario

Sanatorio Parque

ARS Médica

Patrocinadores