A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-011199
NCT ID: NCT03871816
Sponsor Protocol Number: 64091742PCR0002
About this study
The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair defects in a population of men with metastatic Prostate Cancer (PC), and to use the variants reported to assess biomarker eligibility for niraparib interventional studies.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Men, ≥ 18 years of age.
- 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; (i.e., clearly noted in hospital/clinical records). Subjects must have mHSPC as defined by starting androgen deprivation therapy (ADT) (surgical or chemical castration) within 6 months of enrollment
- 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 (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 for genomic analysis.
- No prior PARPi for the treatment of prostate cancer.
- No prior DNA-repair gene defect results from the same assay performed on a Janssen-sponsored interventional trial
- No more than 90 days of prior abiraterone acetate therapy and no prior therapy with other next generation androgen signaling inhibitor therapy (e.g., enzalutamide, apalutamide, darolutamide).
- No more than 6 months of androgen deprivation therapy for treatment of metastatic prostate cancer.
Exclusion Criteria:
Eligibility last updated 9/28/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Cassandra Moore, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available