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Активно (без набиране) Фаза 3 NCT03748641

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

Фаза 3 – широко изпитване преди одобрение
Заболявания: Castration-Resistant Prostatic Cancer

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria: * HRR gene alteration (as identified by the sponsor's required assays) as follows: 1. Cohort 1: positive for HRR gene alteration 2. Cohort 2: not positive for DRD (that is, HRR gene alteration) 3. 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) Exclusion Criteria: * 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
Места на провеждане 28
Argentina (1)
Hospital Aleman
Buenos Aires
Австралия (1)
Royal Adelaide Hospital
Adelaide
Белгия (1)
OLV Ziekenhuis Aalst
Aalst
Бразилия (1)
Fundacao Pio XII
Barretos
България (1)
MHAT Deva Maria
Burgas
Канада (1)
Southern Alberta Institute of Urology / Prostate Cancer Centre
Calgary , Alberta
Китай (1)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Чехия (1)
Fakultni nemocnice Hradec Kralove
Hradec Králove
Франция (1)
CHRU De Besancon
Besançon
Германия (1)
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
Braunschweig
Унгария (1)
Semmelweis Egyetem, Urológia Klinika
Budapest
Израел (1)
Asaf Harofe Medical Center
Beer Yaakov
Италия (1)
AUSL Romagna - Ospedale di Faenza
Faenza
Malaysia (1)
Hospital Pulau Pinang
George Town
Mexico (1)
iBiomed Research Unit
Aguascalientes
Нидерландия (1)
Antoni van Leeuwenhoek
Amsterdam
Полша (1)
Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
Bydgoszcz
Puerto Rico (1)
VA Caribbean Healthcare System
San Juan
Russia (1)
Altai Regional Oncology Dispensary
Barnaul
South Africa (1)
Clinresco Centres Pty Ltd
Johannesburg
Южна Корея (1)
Pusan National University Hospital
Busan
Испания (1)
Hospital Juan Canalejo
A Coruña
Швеция (1)
Sodersjukhuset
Stockholm
Taiwan (1)
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City
Турция (1)
Cukurova University, Faculty of Medicine
Adana
Ukraine (1)
CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
Cherkasy
Великобритания (1)
Royal Blackburn Hospital
Blackburn
САЩ (1)
Urology Centers Of Alabama
Homewood , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Само мъже
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
25.01.2019
Крайна дата
27.02.2027
Регистрационен номер
NCT03748641
Източник
anzctr
Запитване за медицински туризъм

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