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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
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 moreOther 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 • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
22%
Dyspnea
17%
Platelet count decreased
17%
Headache
17%
Mucositis oral
17%
Creatinine increased
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Sinus tachycardia
9%
Cough
9%
Dehydration
9%
Urinary tract infection
9%
Dry mouth
9%
Hypertension
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
Upper respiratory infection
4%
Hoarseness
4%
Hypotension
4%
Hot flashes
4%
Head injury
4%
Hypokalemia
4%
Hyponatremia
4%
Flu like symptoms
4%
Hyperglycemia
4%
Neutrophil count decreased
4%
Tremor
4%
Diarrhea
4%
Depression
4%
Itchy eyes
4%
Oral petechia
4%
Edema limbs
4%
Bruising
4%
Esophageal ulcer
4%
Hyperkalemia
4%
Peripheral sensory neuropathy
4%
Leukocytosis
4%
White blood cell decreased
4%
Postnasal drip
4%
Skin tear
4%
Lung infection
4%
Bloating
4%
Unknown infection
4%
Hematuria
4%
Ascites
4%
Sinus pain
4%
Sore throat
4%
Syncope
100%
80%
60%
40%
20%
0%
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
~2140
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,148 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
NRG OncologyLead Sponsor
238 Previous Clinical Trials
103,069 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