Precision-Based Genomics in Prostate Cancer
A Multi-Center Natural History Study of Precision-Based Genomics in Prostate Cancer
2 other identifiers
observational
2,000
1 country
11
Brief Summary
Background: Prostate cancer is the most common cancer and the second leading cause of death in males in the United States. Researchers want to find additional gene mutations that may increase a man s risk for prostate cancer and may affect how aggressive the disease is. Objective: To look at gene mutations in men with prostate cancer as well as the course of their disease to better understand how gene mutations relate to the way the cancer progresses and responds to treatment. Eligibility: Adult males 18 and older with prostate cancer who have at least one of the gene mutations researchers want to study and/or have been treated for their cancer and have had complete elimination of their cancer or stable disease for a long time. Design: Participants will be screened with a review of their medical records. Their gene test results will be reviewed, if available. They will be asked questions over the phone or in person. Participants do not need to visit the NIH for this study. But if they visit NIH for another study, their data and test results will be collected. They may give blood and urine samples. They may give leftover tumor samples. These samples will be used to study their genes. Participants who do not come to NIH on regular basis will be contacted every 6 months by phone or e-mail. They will be asked questions about their health. Data from their medical records will be collected. Participants will have testosterone and prostate-specific antigen (PSA) tests. Participants may be invited to NIH to give blood samples for research. Participants on this study will be followed for life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedStudy Start
First participant enrolled
September 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
April 24, 2026
April 22, 2026
4.8 years
January 12, 2021
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
natural history of prostate cancer with known germline and/or somatic variants
clinical presentation, patterns of disease progression, therapeutic response, disease recurrence and participant overall survival
ongoing
natural history of TMB-H prostate cancer
clinical presentation, patterns of disease progression, therapeutic response, disease recurrence and participant overall survival
ongoing
Study Arms (2)
Cohort 1
Subjects with histologically confirmed prostate cancer and genomic testing results
Cohort 2
Subjects with histologically confirmed prostate cancer who deemed to be an exceptional responder with or without genomic testing results
Eligibility Criteria
primary clinical
You may qualify if:
- Subjects with histologically confirmed prostate cancer.
- Must have known germline and/or somatic variants in PIK3 and/or AKT, PALB2, BRIP1, RAD50, RAD51, RAD54, RB1, SPOP, Wnt/B-catenin pathway, CDK12, and/or MMR genes: MLH1, MSH2, MSH6, PMS2, and EPCAM and/or TMB-high(\[defined as greater than or equal to 10 mutations/megabase (mut/Mb) and/or bTMB \[greater than or equal to 16 mut/Mb\]. NOTE: any platform for genomics testing is acceptable (research or CLIA-certified)
- be deemed an exceptional responder. NOTE: an exceptional response is defined as achievement of either a) a complete response, or b) a confirmed partial response in a trial or treatment or a response of exceptionally long duration
- Age greater than or equal to 18 years old.
- Ability of subject to understand and the willingness to sign a written informed consent document.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of California San Diego
La Jolla, California, 92093, United States
University of California San Francisco
San Francisco, California, 94143, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Dana Farber Cancer Institute, Boston, MA
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10007, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
University of Washington
Seattle, Washington, 98195, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fatima H Karzai, M.D.
National Cancer Institute (NCI)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 13, 2021
Study Start
September 14, 2021
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
April 24, 2026
Record last verified: 2026-04-22
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active
- Access Criteria
- Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.
All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@ In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.