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GALAHAD: Niraparib for Prostate Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if niraparib is safe and effective for men who have advanced prostate cancer.

What is the Condition Being Studied?

Advanced prostate cancer with a particular type of genetic mutation.

Who Can Participate in the Study?

Adult males who have prostate cancer with a particular type of genetic marker.

Age Group
Adults

What is Involved?

If you agree to join this study, you will:
- Have a pre-screening period during which your tumor tissue and blood will be analyzed to see if your cancer has a mutation that may make it susceptible to niraparib.

After pre-screening, you will:
- Receive the study drug niraparib which you will take by mouth
- Come to clinic every 2 weeks for the first 4 visits and every 12 weeks thereafter.
- At each visit, you will have tests including labs and see a provider and study nurse.
- Have imaging done every 8-12 weeks.

You will receive the study drug (niraparib) as long as you are tolerating it

Study Details

Full Title
A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration- Resistant Prostate Cancer and DNA-Repair Anomalies
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00081275
NCT:NCT02854436
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698