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PARP Inhibitor

Niraparib for Prostate Cancer

Phase 2
Waitlist Available
Led By Vivek Narayan, MD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have received at least 9 weeks of platinum-based chemotherapy for the treatment of mCRPC as the proximal treatment regimen prior to study screening. Patients must not have evidence of clinical or radiographic disease progression (per Investigator assessment) and should have adequately recovered from chemotherapy-related toxicities (at least 4 weeks following completion of chemotherapy, with treatment-related toxicities ≤ grade 1 per CTCAE version 5)
Documented evidence of a pathogenic or likely pathogenic DNA repair aberration in BRCA1/2, ATM, FANCA, PALB2, CHEK2, HDAC2, or BRIP1 through either somatic or germline testing from a CLIA certified laboratory
Must not have
Prior therapy with a PARP inhibitor
Prostate cancer with histologic evidence for pure small cell histology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing an investigational drug, niraparib, for patients with prostate cancer who have recently received platinum-based chemotherapy. The study enrolls participants who have advanced prostate cancer that is still growing despite standard hormone therapies.

Who is the study for?
Men with advanced prostate cancer that's still growing despite hormone therapy and have had recent platinum-based chemo can join. They need a confirmed diagnosis, good performance status, no small cell histology, specific DNA repair defects, and must not have used PARP inhibitors before. Adequate organ function is required.
What is being tested?
The trial tests Niraparib pills for safety and effectiveness in men whose prostate cancer has resisted standard treatments but responded to platinum chemotherapy. It focuses on those with certain genetic changes related to DNA repair.
What are the potential side effects?
While the side effects of Niraparib in this specific setting will be studied during the trial, common ones from similar settings include nausea, fatigue, blood count issues (like anemia), heart palpitations, digestive problems, and shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've completed at least 9 weeks of platinum-based chemotherapy for mCRPC without disease progression.
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My test shows a genetic change linked to cancer in certain genes.
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My kidneys work well enough, with a creatinine clearance rate of at least 45 mL/min.
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I have never been treated with PARP inhibitors.
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My prostate cancer is resistant to hormonal therapy, and I am on or will continue androgen deprivation therapy.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with a PARP inhibitor before.
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My prostate cancer is confirmed to be of a specific type under the microscope.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
rPFS6
Secondary study objectives
Frequency and severity of adverse events (AEs)
Overall survival (OS)
PSA30
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Niraparib Arm (only arm)Experimental Treatment1 Intervention
Niraparib 200 mg by mouth daily (2 x 100 mg pills) on a 28 day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib Pill
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
418 Previous Clinical Trials
463,816 Total Patients Enrolled
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,343 Total Patients Enrolled
Vivek Narayan, MDPrincipal InvestigatorAmbramson Cancer Center of the University of Pennsylvania
4 Previous Clinical Trials
154 Total Patients Enrolled

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04288687 — Phase 2
Prostate Adenocarcinoma Research Study Groups: Niraparib Arm (only arm)
Prostate Adenocarcinoma Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT04288687 — Phase 2
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04288687 — Phase 2
~2 spots leftby Jan 2026
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