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PARP Inhibitor
Pre-Surgery Niraparib for Prostate Cancer
Phase 2
Recruiting
Led By Marc Dall'Era
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically or cytologically confirmed prostate cancer that is clinically localized as defined by negative cross-section imaging and/or bone scan, and classified as high or very high risk per National Comprehensive Cancer Network (NCCN) guideline
Must be able to swallow whole capsules
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial studies niraparib before surgery in treating patients with localized high risk prostate cancer with alterations in DNA repair pathways.
Who is the study for?
Men with high-risk localized prostate cancer and specific DNA repair gene alterations (like BRCA1/2, ATM) can join. They must have chosen surgery as primary treatment and not received prior therapies like PARP inhibitors or hormone therapy. Participants need to be able to swallow capsules, avoid sperm donation, use condoms, and have a life expectancy of at least 10 years.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Niraparib before surgery in patients with high-risk prostate cancer that hasn't spread elsewhere. The focus is on those with certain gene mutations affecting DNA repair who haven't had previous treatments that could interfere.See study design
What are the potential side effects?
Niraparib may cause side effects such as nausea, fatigue, blood cell count changes leading to increased infection risk or anemia, heart rhythm problems (QTc prolongation), digestive issues, liver enzyme changes, and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is confirmed, localized, and high risk according to NCCN guidelines.
Select...
I can swallow whole capsules.
Select...
I have chosen surgery as my main treatment for prostate cancer.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic response rate (pRR)
Secondary outcome measures
Biochemical prostate specific antigen (PSA) progression free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (niraparib)Experimental Treatment3 Interventions
Patients receive niraparib PO QD on days 1-28. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Following completion of treatment, patients then undergo standard of care surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540
Radical Prostatectomy
2005
Completed Phase 2
~4550
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,553 Total Patients Enrolled
13 Trials studying Prostate Cancer
1,799 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,613 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,065 Patients Enrolled for Prostate Cancer
Marc Dall'Era, MDLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is confirmed, localized, and high risk according to NCCN guidelines.I have been treated with a PARP inhibitor before.I have a history of serious irregular heartbeats.I can swallow whole capsules.I have a condition that affects how my body absorbs food.I have received treatment for prostate cancer before.I have chosen surgery as my main treatment for prostate cancer.My prostate cancer has specific gene changes related to DNA repair.I am on HIV medication that might affect the study drug.I am not on antiretroviral therapy.I am fully active or restricted in physically strenuous activity but can do light work.My kidney function, measured by creatinine clearance, is good.My hemoglobin level is at least 9 g/dL, possibly after a transfusion.I am taking medication that affects my heart's rhythm and cannot stop it for the study.I am not allergic to niraparib or its ingredients.You need to either use a condom during sex or choose not to have sex at all.You are expected to live for at least 10 more years.I have been treated with hormone therapy for my cancer.I haven't changed my HIV medication in the last 6 months, unless to avoid a drug interaction.My blood clotting tests are within the normal range.My liver function tests are within the required range.I have had a serious infection related to AIDS in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (niraparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What makes this research so innovative?
"Myriad Genetics, Inc. first ran a clinical trial for Niraparib in 2016. This study completed Phase 3 and 733 people participated across 49 countries in 476 cities. 28 more trials have been conducted since then."
Answered by AI
What is the Niraparib research landscape?
"There are a total of 96 clinical trials currently underway to research Niraparib. 13 of those studies are in the final Phase 3 stage. The majority of these pharmaceutical trials take place in Washington, D.C., but there 2645 different locations around the world conducting similar research."
Answered by AI
To what extent does Niraparib pose a threat to people?
"There is some data supporting Niraparib's safety, but none yet attesting to its efficacy. For this reason, it received a score of 2."
Answered by AI
Are we still enrolling patients in this experiment?
"That is correct. The clinical trial in question, which was posted on February 25th 2020 and updated October 27th 2020, appears to be actively recruiting patients according to the data available on clinicaltrials.gov. They are currently looking for 30 participants at 1 location."
Answered by AI
How many people are allowed to participate in this research project at one time?
"That is correct. The website clinicaltrials.gov has updated information regarding this study, which was first posted on February 25th 2020 and last updated October 27th 2020. Currently, the trial is enrolling 30 patients from 1 site."
Answered by AI
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