An observational study in Metastatic Prostate Cancer, sponsored by Janssen Research & Development, LLC. Completed at 338 sites in 25 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by Janssen Research & Development, LLC · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 14,532 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
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Study population consists of male participants diagnosed with metastatic prostate cancer who will be evaluated for the prevalence for DNA-repair gene defects.
Inclusion Criteria:
Participants with metastatic prostate Cancer (PC) will be evaluated for the prevalence of DNA-repair gene defects (DRDs) and will be assessed for biomarker eligibility status for niraparib interventional studies. Participants will be consented to saliva, blood, and/or archival tumor tissue testing for the presence or absence of DNA-repair gene defects.
Other: Saliva, 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.
Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Prostate Cancer as an Estimate for Prevalence
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.
Time frame: Approximately 2.4 years
Percentage of Participants who Meet Biomarker Eligibility Criteria for Other Niraparib Interventional Studies
Percentage of participants who meet biomarker eligibility criteria for other niraparib interventional studies will be assessed.
Time frame: Approximately 2.4 years
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
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.
Time frame: Approximately 2.4 years
Percentage of Participants with 1 or more DNA-repair gene defects with Metastatic Prostate Cancer as an Estimate for Prevalence
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.
Time frame: Approximately 2.4 years
Showing the first 100 of 338 sites across 25 countries.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC