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Active (not recruiting) Phase 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

Phase 3 – large-scale trial before approval
Conditions: Castration-Resistant Prostatic Cancer

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 28
Argentina (1)
Hospital Aleman
Buenos Aires
Australia (1)
Royal Adelaide Hospital
Adelaide
Belgium (1)
OLV Ziekenhuis Aalst
Aalst
Brazil (1)
Fundacao Pio XII
Barretos
Bulgaria (1)
MHAT Deva Maria
Burgas
Canada (1)
Southern Alberta Institute of Urology / Prostate Cancer Centre
Calgary , Alberta
China (1)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Czech Republic (1)
Fakultni nemocnice Hradec Kralove
Hradec Králove
France (1)
CHRU De Besancon
Besançon
Germany (1)
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
Braunschweig
Hungary (1)
Semmelweis Egyetem, Urológia Klinika
Budapest
Israel (1)
Asaf Harofe Medical Center
Beer Yaakov
Italy (1)
AUSL Romagna - Ospedale di Faenza
Faenza
Malaysia (1)
Hospital Pulau Pinang
George Town
Mexico (1)
iBiomed Research Unit
Aguascalientes
Netherlands (1)
Antoni van Leeuwenhoek
Amsterdam
Poland (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
South Korea (1)
Pusan National University Hospital
Busan
Spain (1)
Hospital Juan Canalejo
A Coruña
Sweden (1)
Sodersjukhuset
Stockholm
Taiwan (1)
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City
Turkey (1)
Cukurova University, Faculty of Medicine
Adana
Ukraine (1)
CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
Cherkasy
United Kingdom (1)
Royal Blackburn Hospital
Blackburn
United States (1)
Urology Centers Of Alabama
Homewood , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
18 Years
Healthy volunteers
No
Start date
25.01.2019
Completion date
27.02.2027
Registry ID
NCT03748641
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.