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

Completed

Conditions studied: Metastatic Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03871816

Run by

Janssen Research & Development, LLC

People needed

14532

Starts

2019-04-22

Expected to finish

2022-11-22

Last updated by the study team

2023-12-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• 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
• Sansum Clinic Pharm — Santa Barbara, California, United States
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Foothills Urology - Golden Off — Golden, Colorado, United States
• Eastern Connecticut Hematology & Oncology Assoc. — Norwich, Connecticut, United States
• Advanced Urology Institute — Daytona Beach, Florida, United States
• Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center — Fort Lauderdale, Florida, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, United States
• Miami Cancer Institute at Baptist Health / Baptist Health Medical Group — Miami, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Woodlands Medical Specialists, PA — Pensacola, Florida, United States
• University Cancer & Blood Center, LLC — Athens, Georgia, United States
• Hawaii Cancer Care — Honolulu, Hawaii, United States
• Affiliated Oncologists, LLC — Chicago Ridge, Illinois, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• Urology Centers Of Alabama — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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