Recent Updates
Recently added Catalysts

Niraparib

Phase 3

Metastatic Castration-sensitive Prostate Cancer | Small molecule | Oncology |Johnson & Johnson|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment696
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04497844A 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)PHASE3 ACTIVE NOT_RECRUITING 696Sep 23, 2020Nov 1, 2027Jun 5, 2026387 United States, Argentina +31
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
From date of randomization (Day -3 to Day 1) up to approximately 49 months

rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors (RECIST) 1.1; (2) progression of bone lesions observed by bone scan per prostate cancer working group 3 (PCWG3) criteria: bone progression was confirmed by subsequent scan greater than or equal to (\>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with \>=2 new lesions indicated progression; A confirmatory scan not showing \>=2 new lesions means no progression. If Week 8 scan shows \<2 new bone lesions compared to baseline, first scan with \>=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan \>=6 weeks later.

HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
From date of randomization (Day -3 to Day 1) up to approximately 49 months

rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per PCWG3 criteria: bone progression was confirmed by subsequent scan \>= 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with \>=2 new lesions indicated progression; A confirmatory scan not showing \>=2 new lesions means no progression. If Week 8 scan shows \<2 new bone lesions compared to baseline, first scan with \>=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan \>=6 weeks later.

All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
From date of randomization (Day -3 to Day 1) up to approximately 49 months

rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per PCWG3 criteria: bone progression was confirmed by subsequent scan \>= 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with \>=2 new lesions indicated progression; A confirmatory scan not showing \>=2 new lesions means no progression. If Week 8 scan shows \<2 new bone lesions compared to baseline, first scan with \>=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan \>=6 weeks later.

Secondary Endpoints
BRCA Subgroup: Time to Symptomatic Progression
From date of randomization (Day -3 to Day 1) up to approximately 49 months
HRR Effector Subgroup: Time to Symptomatic Progression
From date of randomization (Day -3 to Day 1) up to approximately 49 months
All HRR: Time to Symptomatic Progression
From date of randomization (Day -3 to Day 1) up to approximately 49 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Niraparib with Abiraterone Acetate plus Prednisone (AAP)EXPERIMENTALParticipants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily.
AA plus Prednisone (AAP)ACTIVE_COMPARATORParticipants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily.
Interventions
NameTypeDescription
NiraparibDRUGParticipants will receive Niraparib 200 mg once daily.
Abiraterone acetate (AA)DRUGParticipants will receive AA 1000 mg once daily.
PrednisoneDRUGParticipants will receive prednisone 5 mg once daily.
Placebo for NiraparibDRUGParticipants will receive matching placebo for Niraparib once daily.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites387

Inclusion criteria: * Pathological diagnosis of prostate adenocarcinoma * Must have appropriate deleterious homologous recombination repair (HRR) gene alteration * Metastatic disease as documented by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (for soft ti...

Countries:United StatesArgentinaAustraliaBelarusBelgiumBrazilBulgariaCanadaChinaCzechiaDenmarkFranceGermanyHungaryIsraelItalyMalaysiaMexicoNetherlandsNew ZealandPolandPortugalPuerto RicoRussiaSouth AfricaSouth KoreaSpainSwedenTaiwanThailandTurkey (Türkiye)UkraineUnited Kingdom
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT04497844lastUpdatePostDate: changed
LOWJun 5, 2026NCT04497844lastUpdatePostDate: changed
LOWJun 5, 2026NCT04497844lastUpdatePostDate: changed
LOWJun 5, 2026NCT04497844lastUpdatePostDate: changed
LOWMay 26, 2026NCT04497844primaryCompletionDate: changed
LOWMay 24, 2026NCT04497844studyFirstPostDate: changed