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Hormone Therapy

Niraparib 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

NADIR Trial 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
  • Prostate Cancer

NADIR Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maintenance of disease-free state
Secondary outcome measures
Biochemical Progression-Free Survival
Incidence of Adverse Events (Phase II)
Overall Survival
+4 more
Other outcome measures
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%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Vomiting
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Back pain
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Flu like symptoms
4%
Leukocytosis
4%
Oral petechia
4%
Sinus pain
4%
Syncope
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Depression
4%
Edema limbs
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Head injury
4%
Postnasal drip
4%
Hypokalemia
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

NADIR 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
~1540
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,092 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 Patients Enrolled for Prostate Cancer
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,672 Total Patients Enrolled
20 Trials studying Prostate Cancer
12,301 Patients Enrolled for Prostate Cancer
M. D MichaelsonPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
70 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what scenarios is Niraparib employed as a therapeutic agent?

"The medication Niraparib is useful for treating issues related to ovarian stimulation, spermatogenesis, and serious follicle-stimulating hormone deficiency."

Answered by AI

Are there any existing precedents for Niraparib-focused research?

"In 2003, the Rebecca and John Moores UCSD Cancer Center first explored Niraparib. Since then, 238 clinical trials have concluded while 162 are still underway; particularly in Atlanta Georgia."

Answered by AI

How widespread is the execution of this clinical endeavor in Canada?

"This ongoing clinical trial is currently being run across 76 different sites, in cities such as Atlanta, Lee's Summit and Oconomowoc. It may be beneficial to join a nearby location so that any necessary travel can be minimized."

Answered by AI

What is the risk profile associated with the use of Niraparib?

"With Phase 2 clinical trials offering some data on safety, we at Power have provisionally rated Niraparib's safety as a 2. There is currently no evidence to suggest efficacy for this drug."

Answered by AI

What is the scope of enrolment for this clinical trial?

"Affirmative. According to information available on clinicaltrials.gov, this investigation has been actively recruiting participants since June 3rd 2019 and was recently updated on September 27th 2022. 180 patients need to be recruited from 73 separate trial sites."

Answered by AI

Are additional participants currently being sought for this clinical trial?

"According to the information posted on clinicaltrials.gov, this research is actively recruiting subjects and was first made available on June 3rd, 2019; with the most recent update occurring on September 27th, 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer
2019. "Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04037254.
~79 spots leftby Jan 2028
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