Niraparib for Prostate Cancer

University of California Davis Comprehensive Cancer Center, Sacramento, CA
Prostate Cancer+16 More ConditionsNiraparib - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial studies niraparib before surgery in treating patients with localized high risk prostate cancer with alterations in DNA repair pathways.

Eligible Conditions
  • Prostate Cancer
  • FANCL Gene Mutation
  • BRCA1 Gene Mutation
  • ATM Gene Mutation
  • DNA Repair Gene Mutation
  • GEN1 Gene Mutation
  • CHEK1 Gene Mutation
  • BRIP1 Gene Mutation
  • CHEK2 Gene Mutation
  • RAD51C Gene Mutation
  • BRCA2 Gene Mutation
  • Fanconi Anemia
  • Nijmegen Breakage Syndrome
  • CDK12 Gene Mutation
  • DNA Damage Response Gene Mutation
  • RAD51 Gene Mutation
  • FANCD2 Gene Mutation

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
FMS Inhibitor JNJ-40346527
1
Botensilimab and balstilimab (bot/bal)
1
Stravix lyopreserved placental tissue (LPT)

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 5 years

At the time of radical prostatectomy procedure
Pathologic response rate (pRR)
Up to 5 years
Biochemical prostate specific antigen (PSA) progression free survival

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
FMS Inhibitor JNJ-40346527
2
Botensilimab and balstilimab (bot/bal)
2
Stravix lyopreserved placental tissue (LPT)

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Treatment (niraparib)
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Niraparib · No Placebo Group · Phase 2

Treatment (niraparib)Experimental Group · 3 Interventions: Niraparib, Niraparib Tosylate Monohydrate, Radical Prostatectomy · Intervention Types: Drug, Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved
Radical Prostatectomy
2005
Completed Phase 2
~4520

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,276 Previous Clinical Trials
41,234,687 Total Patients Enrolled
542 Trials studying Prostate Cancer
503,565 Patients Enrolled for Prostate Cancer
University of California, DavisLead Sponsor
866 Previous Clinical Trials
5,026,852 Total Patients Enrolled
10 Trials studying Prostate Cancer
600 Patients Enrolled for Prostate Cancer
Janssen, LPIndustry Sponsor
149 Previous Clinical Trials
202,293 Total Patients Enrolled
5 Trials studying Prostate Cancer
379 Patients Enrolled for Prostate Cancer
Marc Dall'EraPrincipal InvestigatorUniversity of California, Davis

Eligibility Criteria

Age 18+ · Male Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to be able to swallow pills without crushing or chewing them.
You are expected to live for at least 10 more years.
Men who have chosen surgery as their main treatment for prostate cancer.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top