Status:
COMPLETED
A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
18+ years
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
14532 Patients enrolled
Trial Details
Trial ID
NCT03871816
Start Date
April 22 2019
End Date
November 22 2022
Last Update
December 11 2023
Active Locations (338)
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1
Urology Centers Of Alabama
Homewood, Alabama, United States, 35209
2
Southern Cancer Center, PC
Mobile, Alabama, United States, 36608
3
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States, 85016
4
Mayo Clinic
Phoenix, Arizona, United States, 85054