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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,683 Total Patients Enrolled
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,083 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

Frequently Asked Questions

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

How many participants have enrolled in the experiment thus far?

"Affirmative. According to information shared via clinicaltrials.gov, this research is actively recruiting participants; the trial was initially made available on October 19th 2020 and its details were most recently updated on March 29th 2022. The study seeks 18 subjects from a single location."

Answered by AI

Are there precedents for this treatment that have been tested in clinical trials?

"Presently, there are ninety-nine clinical trials being conducted for this treatment. Thirteen of these live experiments have entered Phase 3. While most studies are located in Washington D.C., 2817 other sites across the country host research on this intervention."

Answered by AI

Is this research pioneering in its field?

"Myriad Genetics, Inc. initiated the earliest research into this treatment in 2016 when they sponsored a trial involving 733 patients. This ultimately led to Phase 3 drug approval and today there are over 99 active trials for it transpiring across 49 countries and 485 cities."

Answered by AI

Has this intervention been sanctioned by the appropriate regulatory body?

"Evidence of the safety profile is present, thus receiving a score of 2. Since this is only Phase 2, there are no clinical data yet that support its efficacy."

Answered by AI

Are there any available spots for participants in the clinical investigation?

"Affirmative. As indicated by the data on clinicaltrials.gov, this experiment is presently enrolling volunteers. It was first advertised on October 19th 2020 and has since been updated for the last time on March 29th 2022. The medical research requires 18 participants from one facility to take part in it."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects
2020. "A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04288687.
~0 spots leftby Jun 2024
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