Niraparib for Castration Resistant Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Castration Resistant Prostate CancerNiraparib - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial will compare the effect of adding niraparib to abiraterone acetate plus prednisone, versus abiraterone acetate plus prednisone and placebo, in men with metastatic castration-resistant prostate cancer.

Eligible Conditions
  • Castration Resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 66 months

Month 7
Cohort 1: Observed Plasma Concentrations of Niraparib
Month 3
Cohort 1: Observed Trough Plasma Concentrations of Abiraterone
Up to 28 months
Cohort 1 and 3: Radiographic Progression Free Survival (rPFS)
Cohort 1: Time to Initiation of Cytotoxic Chemotherapy
Cohort 1: Time to Symptomatic Progression
Up to 66 months
Cohort 1: Number of Participants with Laboratory Abnormalities as Measure of Safety
Cohort 1: Number of Participants with Treatment-Emergent Adverse events (TEAEs)
Cohort 1: Number of Participants with Treatment-Emergent Adverse events by Severity
Cohort 1: Overall survival (OS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Stage 1 (Cohort 2): Niraparib + Pembrolizumab
57%Nausea
52%Decreased appetite
48%Anaemia
48%Constipation
43%Fatigue
38%Dyspnoea
24%Oedema peripheral
24%Vomiting
24%Stomatitis
24%Platelet count decreased
19%Insomnia
19%Blood alkaline phosphatase increased
19%Arthralgia
19%Pruritus
14%Pneumonia
14%Diarrhoea
14%Cough
14%Pain
14%Chills
14%Upper respiratory tract infection
14%Weight decreased
14%Neutrophil count decreased
14%Dysgeusia
14%Back pain
14%Muscular weakness
10%Depression
10%Erythema
10%Vision blurred
10%Pleural effusion
10%Atrial fibrillation
10%Neuropathy peripheral
10%Haemorrhoids
10%Haemorrhoidal haemorrhage
10%Anxiety
10%Proctalgia
10%Oropharyngeal pain
10%Wheezing
10%Non-cardiac chest pain
10%Productive cough
10%Gait disturbance
10%Chest pain
10%Urinary tract infection
10%Hypophosphataemia
10%Aspartate aminotransferase increased
10%Dehydration
10%Blood creatinine increased
10%Hypokalaemia
10%Lymphocyte count decreased
10%Alanine aminotransferase increased
10%Rash maculo-papular
10%Pain of skin
10%Overdose
10%Hypothyroidism
5%Angina pectoris
5%Dizziness
5%Sepsis
5%Dysphonia
5%Sinus tachycardia
5%Neuroendocrine carcinoma of the skin
5%Gastrooesophageal reflux disease
5%Candida infection
5%Fall
5%Pulmonary embolism
5%Pneumonitis
5%Respiratory failure
5%Cardiac arrest
5%Pericardial effusion
5%Intestinal obstruction
5%Lactic acidosis
5%Diverticulitis
5%Lethargy
5%Headache
5%Cancer pain
5%Toxicity to various agents
5%Abdominal pain
5%Haematochezia
5%Nasal congestion
5%Asthenia
5%Pyrexia
5%Malaise
5%Hypomagnesaemia
5%Hyponatraemia
5%Amylase increased
5%Hepatic enzyme increased
5%Peripheral sensory neuropathy
5%Pain in extremity
5%Hyperhidrosis
5%Tachycardia
5%Contusion
5%Hypotension
5%Lipase increased
5%Syncope
5%Hyperglycaemia
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03308942) in the Stage 1 (Cohort 2): Niraparib + Pembrolizumab ARM group. Side effects include: Nausea with 57%, Decreased appetite with 52%, Anaemia with 48%, Constipation with 48%, Fatigue with 43%.

Trial Design

3 Treatment Groups

Cohort 2: Participants with mCRPC and No HRR Gene Alteration
1 of 3
Cohort 3 (Open-label): Participants with mCRPC
1 of 3
Cohort 1: Participants with mCRPC and HRR Gene Alteration
1 of 3

Experimental Treatment

765 Total Participants · 3 Treatment Groups

Primary Treatment: Niraparib · Has Placebo Group · Phase 3

Cohort 2: Participants with mCRPC and No HRR Gene AlterationExperimental Group · 4 Interventions: Prednisone, Niraparib, Abiraterone Acetate, Placebo · Intervention Types: Drug, Drug, Drug, Drug
Cohort 3 (Open-label): Participants with mCRPCExperimental Group · 2 Interventions: New Formulation of Niraparib and Abiraterone Acetate (AA), Prednisone · Intervention Types: Drug, Drug
Cohort 1: Participants with mCRPC and HRR Gene AlterationExperimental Group · 4 Interventions: Prednisone, Niraparib, Abiraterone Acetate, Placebo · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved
Niraparib
FDA approved
Abiraterone
FDA approved
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 66 months

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
924 Previous Clinical Trials
6,330,352 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
710 Previous Clinical Trials
3,903,337 Total Patients Enrolled
1 Trials studying Castration Resistant Prostate Cancer
45 Patients Enrolled for Castration Resistant Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to continue GnRHa during the study if not surgically castrate.
You have a positive result for the HRR gene alteration.
You have metastatic prostate cancer and low levels of testosterone (<=) 50 ng/dL