Niraparib for Stage IVA Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Stage IVA Prostate Cancer+6 MoreNiraparib - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is studying niraparib as a possible treatment for prostate cancer. It is testing how well it works with standard treatments of radiation and hormonal therapy, and what the side effects are.

Eligible Conditions
  • Stage IVA Prostate Cancer
  • Prostate Adenocarcinoma
  • Stage III Prostate Cancer
  • Stage II Prostate Cancer
  • Stage IIIA Prostate Cancer
  • Stage IIIB Prostate Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 3 years

At 24 months
Pathologic Complete Response (pCR)
Year 3
Overall Survival
Year 3
Prostate cancer-specific survival
Year 3
Time to distant metastases
Year 2
Maintenance of disease-free state
Up to 3 years
Biochemical Progression-Free Survival
Exome sequencing of deoxyribonucleic acid (DNA) repair genes and detected alterations
Incidence of Adverse Events (Phase II)
Single nucleotide polymorphisms
Time to local/regional or distant progression
Transcription-wide analysis of gene expression

Trial Safety

Safety Progress

2 of 3
This is further along than 68% 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

Phase II, Arm I (GnRH, IMRT)
1 of 3
Phase II, Arm II (niraparib, GnRH, IMRT)
1 of 3
Phase I (niraparib, GnRH, IMRT)
1 of 3

Active Control

Experimental Treatment

180 Total Participants · 3 Treatment Groups

Primary Treatment: Niraparib · No Placebo Group · Phase 2

Phase II, Arm II (niraparib, GnRH, IMRT)Experimental Group · 3 Interventions: Gonadotrophin Releasing Hormone, Niraparib, Intensity-Modulated Radiation Therapy · Intervention Types: Biological, Drug, Radiation
Phase I (niraparib, GnRH, IMRT)Experimental Group · 3 Interventions: Gonadotrophin Releasing Hormone, Niraparib, Intensity-Modulated Radiation Therapy · Intervention Types: Biological, Drug, Radiation
Phase II, Arm I (GnRH, IMRT)ActiveComparator Group · 2 Interventions: Gonadotrophin Releasing Hormone, Intensity-Modulated Radiation Therapy · Intervention Types: Biological, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~1660

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

NRG OncologyLead Sponsor
219 Previous Clinical Trials
95,344 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,099 Previous Clinical Trials
41,145,607 Total Patients Enrolled
2 Trials studying Stage IVA Prostate Cancer
400 Patients Enrolled for Stage IVA Prostate Cancer
M. D MichaelsonPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
70 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

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