RECRUITING

Precision-Based Genomics in Prostate Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

A Multi-Center Natural History Study of Precision-Based Genomics in Prostate Cancer

Quick Facts

Study Start:2021-09-14
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04706663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects with histologically confirmed prostate cancer.
  2. * 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)
  3. * 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
  4. * Age greater than or equal to 18 years old.
  5. * Ability of subject to understand and the willingness to sign a written informed consent document.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Katherine O Lee-Wisdom, R.N.
CONTACT
(240) 858-3525
katherine.lee-wisdom@nih.gov
Fatima H Karzai, M.D.
CONTACT
(301) 480-7174
fatima.karzai@nih.gov

Principal Investigator

Fatima H Karzai, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Fatima H Karzai, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-14
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2021-09-14
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • germline variants
  • somatic variants
  • Genetic Predisposition
  • Molecular Genetics
  • Natural History

Additional Relevant MeSH Terms

  • Prostate Cancer