Metastatik Prostat Kanseri Olan Katılımcıların Tedavisinde Niraparib ile Abiraterone Acetate ve Prednisone Kombinasyonunun, Abiraterone Acetate ve Prednisone ile Karşılaştırıldığı Bir Çalışma

Sade dilde özet

Bu çalışma, metastatik prostat kanseri (metastatic prostate cancer) olan hastalarda Niraparib ilacının Abiraterone Acetate ve Prednisone ile birlikte kullanımını, yalnızca Abiraterone Acetate ve Prednisone kullanımı ile karşılaştırmaktadır. Çalışmaya, homolog rekombinasyon onarımı (HRR) genlerindeki değişiklik durumuna göre değerlendirilen, kastrasyon düzeyinde testosterona sahip metastatik prostat kanseri olan hastalar katılabilmektedir. Çalışma Faz 3 aşamasında yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Devam ediyor, katılım kapalı

Sponsor

Janssen Research & Development, LLC

Müdahale

Niraparib, Abiraterone Acetate, Prednisone, Placebo, New Formulation of Niraparib and Abiraterone Acetate (AA)

Başlangıç

25.01.2019

Tahmini bitiş

27.02.2027

Ülkeler

United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

İlgili genler

Merkezler

• Homewood, United States
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• Lancaster, United States
• Pittsburgh, United States
• Myrtle Beach, United States

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Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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