A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer

Status:	Not yet recruiting
Conditions:	Prostate Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/31/2019
Start Date:	April 1, 2019
End Date:	August 4, 2021
Contact:	Study Contact
Email:	JNJ.CT@sylogent.com
Phone:	844-434-4210

Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer

The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair defects in a
population of men with metastatic Prostate Cancer (PC) and to use the variants reported to
assess biomarker eligibility for niraparib interventional studies.

Inclusion Criteria:

- Diagnosis of metastatic (Stage IV) prostate cancer (PC), confirmed by either biopsy of
a metastatic tumor site or history of localized disease supported by metastatic
disease on imaging studies (that is [i.e.], clearly noted in hospital/clinical
records)

- Signed Informed consent form (ICF)

- No condition for which, in the opinion of the investigator, participation would not be
in the best interest of the participant (for example [e.g.], compromise the
well-being) or that could prevent, limit, or confound the protocol-specified
assessments

- Willing to provide a saliva or blood sample for genomic analysis

We found this trial at

sites

Duke Cancer Institute

20 Duke Clinic Cir
Durham, North Carolina 27710

(888) 275-3853