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Hormone Therapy

Niraparib + Standard Therapy for Prostate Cancer (NADIR Trial)

Phase 2

Waitlist Available

Led By M. D Michaelson

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for men with high-risk prostate cancer that hasn't spread elsewhere. Eligible participants have a Gleason score of 7 or higher, PSA levels below certain thresholds, and good organ function. They must not have had prior treatments like radical prostatectomy or systemic therapy for prostate cancer and should be willing to use contraception.

What is being tested?

The study tests the effectiveness of Niraparib (an enzyme blocker) combined with standard radiation and hormonal therapies in preventing the return of high-risk prostate cancer. It's a phase II trial aiming to find the best dose while monitoring side effects.

What are the potential side effects?

Niraparib may cause fatigue, nausea, blood cell count changes, heart palpitations, muscle pain, and other digestive issues. Standard radiation might lead to skin irritation at treatment sites and hormonal therapy can result in hot flashes or reduced sexual interest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maintenance of disease-free state

Secondary study objectives

Biochemical Progression-Free Survival

Incidence of Adverse Events (Phase II)

Overall Survival

+4 more

Other study objectives

Exome sequencing of deoxyribonucleic acid (DNA) repair genes and detected alterations

Single nucleotide polymorphisms

Transcription-wide analysis of gene expression

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347

74%

Fatigue

52%

Nausea

39%

Constipation

39%

Anorexia

30%

Anemia

30%

Alkaline phosphatase increased

26%

Weight loss

22%

Dizziness

22%

Insomnia

22%

Dyspnea

22%

Abdominal pain

17%

Headache

17%

Mucositis oral

17%

Platelet count decreased

17%

Creatinine increased

13%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Urinary tract infection

Cough

Dehydration

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Postnasal drip

Hoarseness

Hypotension

Hot flashes

Peripheral sensory neuropathy

Hyperkalemia

Head injury

Hypokalemia

Hyponatremia

Flu like symptoms

Skin tear

Hyperglycemia

Neutrophil count decreased

Tremor

Bruising

Esophageal ulcer

Diarrhea

Depression

Itchy eyes

Oral petechia

Edema limbs

Upper respiratory infection

Leukocytosis

White blood cell decreased

Lung infection

Bloating

Unknown infection

Hematuria

Ascites

Sinus pain

Sore throat

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort B

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Phase II, Arm II (niraparib, GnRH, IMRT)Experimental Treatment3 Interventions

Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity.

Group II: Phase I (niraparib, GnRH, IMRT)Experimental Treatment3 Interventions

Patients receive niraparib PO QD and receive standard of care GnRH agonist androgen suppression therapy. Treatment with niraparib continues for 12 months, and GnRH agonist therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib and GnRH agonist, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks, depending on type of radiation therapy given, in the absence of disease progression or unacceptable toxicity.

Group III: Phase II, Arm I (GnRH, IMRT)Active Control2 Interventions

Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~2400

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160