A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Titre officiel

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Sommaire:

L’objectif de l’étude consiste à déterminer si l’association du niraparib et de l’acétate d’abiratérone (AA) administrée conjointement avec la prednisone, comparativement à l’association d’AA et de prednisone, chez les participants atteints d’un cancer de la prostate métastatique sensible à la castration (CPMSC) avec mutation délétère, germinale ou somatique, d’un gène de réparation par recombinaison homologue (RRH) offre une efficacité supérieure pour améliorer la survie sans progression radiographique (SSPr).

Description de l'essai

Primary Outcome:

  • Radiographic Progression-free Survival (rPFS)
Secondary Outcome:
  • Overall Survival (OS)
  • Symptomatic Progression-free Survival
  • Time to Subsequent Therapy
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Prostate cancer is a heterogenous disease and recent genomic analyses have highlighted specific germline and somatic mutations and alternative driver growth signaling pathways in patients with metastatic disease. Abiraterone acetate plus prednisone (AA-P) is an established standard of care for the treatment of participants with mCSPC and is included in widely accepted clinical treatment guidelines. Niraparib is an investigational agent in the castration-sensitive cancer population and has been approved for the treatment of ovarian cancer. The addition of niraparib to the AA-P backbone regimen may improve initial disease control and long-term outcomes compared with AA-P alone in a biomarker selected population. The study will consist of 4 phases; a Prescreening Phase for biomarker evaluation for eligibility only, a Screening Phase, a Treatment Phase, and a Follow-up Phase. Efficacy evaluations include the following: tumour measurements by computed tomography (CT), magnetic resonance imaging (MRI; abdomen, chest, and pelvis), Technetium-99m (99mTc) bone scans, serum prostate sensitive antigen (PSA) evaluations, and patient reported outcomes (PROs). Safety evaluations include incidence of adverse events and clinical laboratory parameters.

Voir cet essai sur ClinicalTrials.gov

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