Clinical trial · Observational
A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
NCT03871816CI-TRIAL-00072117completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with Metastatic Prostate Cancer
- description
- 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.
- interventionNames
- Other: Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis
Primary outcomes (2)
- measure
- Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Prostate Cancer as an Estimate for Prevalence
- timeFrame
- Approximately 2.4 years
- 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.
- measure
- Percentage of Participants who Meet Biomarker Eligibility Criteria for Other Niraparib Interventional Studies
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.