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

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ClinicalTrials.gov Identifier: NCT03871816
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date March 11, 2019
First Posted Date March 12, 2019
Last Update Posted Date July 16, 2021
Actual Study Start Date April 22, 2019
Estimated Primary Completion Date July 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2020)
  • Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Prostate Cancer as an Estimate for Prevalence [ Time Frame: 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 [ Time Frame: Approximately 2.4 years ]
    Percentage of participants who meet biomarker eligibility criteria for other niraparib interventional studies will be assessed.
Original Primary Outcome Measures
 (submitted: March 11, 2019)
  • Percentage of Participants with 4 or more DNA-repair Defects with Metastatic Prostate Cancer as an Estimate for Prevalence [ Time Frame: Approximately 2.4 years ]
    Percentage of participants with 4 or more Deoxyribonucleic acid (DNA)-repair defects with metastatic Prostate Cancer (PC) as an estimate for prevalence will be assessed. A saliva or blood sample (or both) or existing tissue sample will be collected for genetic testing to determine if DNA-repair defects are present. The retrieval of archived prostate or metastatic tissue samples is optional.
  • Percentage of Participants who Meet Biomarker Eligibility Criteria for Other Niraparib Interventional Studies [ Time Frame: Approximately 2.4 years ]
    Percentage of participants who meet biomarker eligibility criteria for other niraparib interventional studies will be assessed.
Change History
Current Secondary Outcome Measures
 (submitted: May 21, 2020)
  • 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: March 11, 2019)
  • Percentage of Participants with 4 or more DNA-repair defects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and with Metastatic Hormone Sensitive PC (HSPC) as an Estimate for Prevalence [ Time Frame: Approximately 2.4 years ]
    Percentage of participants with 4 or more DNA-repair defects with mCRPC and HSPC as an estimate for prevalence will be assessed. A saliva or blood sample (or both) or existing tissue samples will be collected for genetic testing to determine if DNA-repair defects are present.
  • Percentage of Participants with 1 or more DNA-repair defects with Metastatic Prostate Cancer as an Estimate for Prevalence [ Time Frame: Approximately 2.4 years ]
    Percentage of participants with 1 or more DNA-repair defects with metastatic PC as an estimate for prevalence will be assessed. A saliva or blood sample (or both) or existing tissue samples will be collected for genetic testing to determine if DNA-repair defects are present.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Official Title Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
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.
Condition Metastatic Prostate Cancer
Intervention 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.
Study Groups/Cohorts Participants with Metastatic Prostate Cancer
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.
Intervention: Other: Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 3, 2020)		 10000
Original Estimated Enrollment
 (submitted: March 11, 2019)		 2540
Estimated Study Completion Date September 18, 2023
Estimated Primary Completion Date July 26, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries Argentina,   Australia,   Belarus,   Belgium,   Brazil,   Bulgaria,   Canada,   Denmark,   France,   Germany,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Netherlands,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries New Zealand
 
Administrative Information
NCT Number NCT03871816
Other Study ID Numbers CR108591
64091742PCR0002 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor Janssen Research & Development, LLC
Collaborators Not Provided
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date July 2021