Metastatic Prostate Cancer
Conditions
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.
Interventions
OTHERSaliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis
Saliva, blood, and/or archival tumor tissue will be collected from the participants with metastatic PC for genomic testing to confirm DRD status.
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Prostate Cancer as an Estimate for Prevalence | Approximately 2.4 years | 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. |
| Percentage of Participants who Meet Biomarker Eligibility Criteria for Other Niraparib Interventional Studies | Approximately 2.4 years | Percentage of participants who meet biomarker eligibility criteria for other niraparib interventional studies will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Approximately 2.4 years | 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. |
| Percentage of Participants with 1 or more DNA-repair gene defects with Metastatic Prostate Cancer as an Estimate for Prevalence | Approximately 2.4 years | 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. |
Countries
Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, Denmark, France, Germany, Israel, Italy, Malaysia, Netherlands, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Outcome results
None listed