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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03871816




Registration number
NCT03871816
Ethics application status
Date submitted
11/03/2019
Date registered
12/03/2019
Date last updated
11/12/2023

Titles & IDs
Public title
A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Scientific title
Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Secondary ID [1] 0 0
64091742PCR0002
Secondary ID [2] 0 0
CR108591
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis

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.


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Prostate Cancer as an Estimate for Prevalence
Timepoint [1] 0 0
Approximately 2.4 years
Primary outcome [2] 0 0
Percentage of Participants who Meet Biomarker Eligibility Criteria for Other Niraparib Interventional Studies
Timepoint [2] 0 0
Approximately 2.4 years
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Approximately 2.4 years
Secondary outcome [2] 0 0
Percentage of Participants with 1 or more DNA-repair gene defects with Metastatic Prostate Cancer as an Estimate for Prevalence
Timepoint [2] 0 0
Approximately 2.4 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/11/2022
Sample size
Target
Accrual to date
Final
14532
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [2] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [4] 0 0
St Vincent's hospital - Darlinghurst
Recruitment hospital [5] 0 0
Border Medical Oncology - East Albury
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
Ashford Cancer Centre - Kurralta Park
Recruitment hospital [8] 0 0
Liverpool Hospital - Liverpool
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Macquarie University Hospital - Macquarie University
Recruitment hospital [10] 0 0
Peter MacCallum Cancer Centre - Melbourne
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Fiona Stanley Hospital - Murdoch
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Prince Of Wales Hospital - Randwick
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Sydney Adventist Hospital - Wahroonga
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4217 - Benowa
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4575 - Birtinya
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2050 - Camperdown
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2010 - Darlinghurst
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2640 - East Albury
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7000 - Hobart
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5037 - Kurralta Park
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2170 - Liverpool
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2109 - Macquarie University
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3000 - Melbourne
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6150 - Murdoch
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2031 - Randwick
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2076 - Wahroonga
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Lviv
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Uzhgorod
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03871816
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03871816