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PARP Inhibitor

Niraparib for Prostate Cancer

Phase 1
Waitlist Available
Led By William Kelly, DO
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic or cytologic diagnosis of adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
Bone metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of niraparib when given with radium Ra223 dichloride to treat subjects with prostate cancer that has spread to the bone and is not responding to hormone therapy.

Eligible Conditions
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose of niraparib to combine with radium Ra 223 dichloride based on dose limiting toxicities graded by National Cancer Institute, Common Toxicity Criteria, version 4.0

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%
Creatinine increased
17%
Platelet count decreased
17%
Mucositis oral
13%
Sinus tachycardia
13%
Vomiting
13%
Aspartate aminotransferase increased
13%
Rash maculo-papular
9%
Back pain
9%
Urinary tract infection
9%
Dehydration
9%
Blood bilirubin increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Depression
4%
Hyperkalemia
4%
Edema limbs
4%
Esophageal ulcer
4%
Neutrophil count decreased
4%
Lung infection
4%
Hypokalemia
4%
Peripheral sensory neuropathy
4%
White blood cell decreased
4%
Sore throat
4%
Skin tear
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Leukocytosis
4%
Syncope
4%
Itchy eyes
4%
Hyponatremia
4%
Flu like symptoms
4%
Postnasal drip
4%
Hypotension
4%
Hoarseness
4%
Sinus pain
4%
Bloating
4%
Diarrhea
4%
Head injury
4%
Oral petechia
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Upper respiratory infection
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (niraparib, radium Ra 223 dichloride)Experimental Treatment2 Interventions
Patients receive niraparib orally daily and radium Ra 223 dichloride IV over 1 minute every 4 weeks. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radium Ra 223 dichloride
FDA approved
Radium Ra 223 Dichloride
2017
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
11,656 Total Patients Enrolled
13 Trials studying Prostate Cancer
2,326 Patients Enrolled for Prostate Cancer
Janssen, LPIndustry Sponsor
158 Previous Clinical Trials
304,944 Total Patients Enrolled
6 Trials studying Prostate Cancer
337 Patients Enrolled for Prostate Cancer
Prostate Cancer Clinical Trials ConsortiumOTHER
10 Previous Clinical Trials
7,224 Total Patients Enrolled
8 Trials studying Prostate Cancer
7,034 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025