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

Completed

• Conditions: Metastatic Prostate Cancer

• Registration Number: NCT03871816
• Lead Sponsor: Janssen Research & Development, LLC

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 available

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-12
• Study Start: 2019-04-22
• Primary Completion: 2022-10-30
• Study Completion: 2022-11-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14532

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 Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Prostate Cancer as an Estimate for Prevalence	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	Approximately 2.4 years	Percentage of participants who meet biomarker eligibility criteria for other niraparib interventional studies will be assessed.

Secondary Outcome Measures

Name	Time	Method
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	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	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.

Trial Locations

Locations (335)

Urology Centers Of Alabama; 🇺🇸 Homewood, Alabama, United States

Southern Cancer Center, PC; 🇺🇸 Mobile, Alabama, United States

Arizona Oncology Associates, PC - HAL; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States

Urological Associates of Southern Arizona, P.C.; 🇺🇸 Tucson, Arizona, United States

Yuma Regional Medical Center; 🇺🇸 Yuma, Arizona, United States

Arkansas Urology; 🇺🇸 Little Rock, Arkansas, United States

MemorialCare Research Miller Children's and Women's Hospital Long Beach; 🇺🇸 Long Beach, California, United States

Kaiser Permanente; 🇺🇸 Riverside, California, United States

San Bernardino Urological Associates; 🇺🇸 San Bernardino, California, United States

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