Brief Summary
The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies.
Brief Title
A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Categories
Completion Date
Completion Date Type
Actual
Conditions
Metastatic Prostate Cancer
Eligibility Criteria
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, blood, and/or archival tumor tissue sample for genomic analysis
* No prior poly (adenosine diphosphate \[ADP\]-ribose) polymerase inhibitor (PARPi) for the treatment of prostate cancer
* No prior DNA-repair gene defect test results from a Janssen sponsored interventional trial
* 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, blood, and/or archival tumor tissue sample for genomic analysis
* No prior poly (adenosine diphosphate \[ADP\]-ribose) polymerase inhibitor (PARPi) for the treatment of prostate cancer
* No prior DNA-repair gene defect test results from a Janssen sponsored interventional trial
Inclusion Criteria
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, blood, and/or archival tumor tissue sample for genomic analysis
* No prior poly (adenosine diphosphate \[ADP\]-ribose) polymerase inhibitor (PARPi) for the treatment of prostate cancer
* No prior DNA-repair gene defect test results from a Janssen sponsored interventional trial
* 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, blood, and/or archival tumor tissue sample for genomic analysis
* No prior poly (adenosine diphosphate \[ADP\]-ribose) polymerase inhibitor (PARPi) for the treatment of prostate cancer
* No prior DNA-repair gene defect test results from a Janssen sponsored interventional trial
Gender
Male
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03871816
Org Class
Industry
Org Full Name
Janssen Research & Development, LLC
Org Study Id
CR108591
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Primary Outcomes
Outcome Description
Percentage of participants with 4 or more Deoxyribonucleic acid (DNA)-repair gene defects with metastatic Prostate Cancer (PC) as an estimate for prevalence will be assessed. A saliva, blood, and/or archival tumor tissue sample will be collected for genomic testing to confirm DNA-repair gene defect (DRD) status.
Outcome Measure
Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Prostate Cancer as an Estimate for Prevalence
Outcome Time Frame
Approximately 2.4 years
Outcome Description
Percentage of participants who meet biomarker eligibility criteria for other niraparib interventional studies will be assessed.
Outcome Measure
Percentage of Participants who Meet Biomarker Eligibility Criteria for Other Niraparib Interventional Studies
Outcome Time Frame
Approximately 2.4 years
Secondary Ids
Secondary Id
64091742PCR0002
Secondary Outcomes
Outcome Description
Percentage of participants with 4 or more DRDs with mCRPC and HSPC as an estimate for prevalence will be assessed. A saliva, blood, and/or archival tumor tissue sample will be collected for genomic testing to confirm DRD status.
Outcome Time Frame
Approximately 2.4 years
Outcome Measure
Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and with Metastatic Hormone Sensitive PC (HSPC) as an Estimate for Prevalence
Outcome Description
Percentage of participants with 1 or more DRDs with metastatic PC as an estimate for prevalence will be assessed. Saliva, blood, and/or archival tumor tissue sample will be collected for genomic testing to confirm DRD status.
Outcome Time Frame
Approximately 2.4 years
Outcome Measure
Percentage of Participants with 1 or more DNA-repair gene defects with Metastatic Prostate Cancer as an Estimate for Prevalence
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Study population consists of male participants diagnosed with metastatic prostate cancer who will be evaluated for the prevalence for DNA-repair gene defects.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Gartrell
Investigator Email
bgartrel@montefiore.org
Investigator Phone
718-405-8404