Genetic Testing for Men With Metastatic Prostate Cancer
NCT ID: NCT03503097
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
799 participants
OBSERVATIONAL
2017-08-21
2025-09-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Collection of Blood From Patients With Prostate Cancer
NCT00923221
Study of Genes and the Environment in Patients With Prostate Cancer Residing in the East Anglia, Trent, or West Midlands Regions of the United Kingdom
NCT00758173
Analysis of Prostate Cancer Short-Term Cultures Using Molecular Cytogenetic Methods
NCT00022919
Prostate Cancer Genomic Heterogeneity
NCT02022371
Prospective Registry of Multiplex Testing (PROMPT)
NCT02665195
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants receive web-based or hard-copy questionnaires and saliva collection kits via mail or in person. Participants also provide saliva samples to be mailed back to Color Genomics for genetic testing once complete. Participants then receive phone-based genetic counseling if they are identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene. All participants have access to phone-based genetic counseling whether or not they are not found to have a mutation.
After study completion, participants are followed up at 6 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ancillary-Correlative (questionnaires, Color kit, counseling)
Participants receive web-based or hard-copy questionnaires and saliva collection kits via mail or in person. Participants also provide saliva samples to be mailed back to Color Genomics for genetic testing once complete. Participants then receive phone-based genetic counseling if they are identified to have an inherited mutation in a DNA repair gene. All participants have access to phone-based genetic counseling whether or not they are not found to have a mutation.
Biospecimen Collection
Provide saliva samples
Genetic Counseling
Undergo counseling
Genetic Testing
Undergo genetic testing
Laboratory Biomarker Analysis
Correlative studies
Questionnaire
Complete questionnaire
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biospecimen Collection
Provide saliva samples
Genetic Counseling
Undergo counseling
Genetic Testing
Undergo genetic testing
Laboratory Biomarker Analysis
Correlative studies
Questionnaire
Complete questionnaire
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documented evidence of metastatic prostate cancer;
* Oncologist note within 4 months
* All computed tomography (CT), bone, positron emission tomography (PET) scan reports within 12 months
* All prostate-specific antigen (PSA) values within 12 months
* All available pathology reports from diagnosis, prostatectomy, and/or metastatic biopsy
* Willingness to provide basic demographic information, family cancer history, and treatment history
* Willingness and ability to complete patient reported outcomes questionnaire (on-line or hard copy) at enrollment, and at 6-month follow-up
* Willingness and ability to provide saliva sample
* Study team members
Exclusion Criteria
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heather H. Cheng
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2018-00533
Identifier Type: REGISTRY
Identifier Source: secondary_id
9831
Identifier Type: OTHER
Identifier Source: secondary_id
RG1001545
Identifier Type: OTHER
Identifier Source: secondary_id
9831
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.