Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study (GIFTS)

July 17, 2026 updated by: Fred Hutchinson Cancer Center

Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer

This trial studies the role of inherited (present at birth) mutations in cancer risk genes such as BRCA2, BRCA1, ATM, CHEK2, and others in relation to prostate cancer. This study may help researchers understand the frequency and importance of inherited mutations in cancer risk genes in patients with prostate cancer and potentially help identify better ways to treat cancer in patients who have a mutation in one of these genes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

OUTLINE:

Participants complete questionnaire over 20 minutes at baseline, then undergo collection of saliva sample for genetic testing. Participants identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene undergo genetic counseling. Participants whose genetic testing does not indicate an inherited mutation in a DNA repair gene receive a letter thanking them for their participation and emphasizing the importance of ongoing communication with their physician and family members about cancer risk. Participants may also receive an educational flyer with or without a educational video regarding prostate cancer and genetic testing.

Participants will be sent newsletters every year to encourage study engagement and update health questionnaires every two years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients living in Washington State with a new diagnosis of prostate cancer and first degree relatives of patients with prostate cancer

Description

Inclusion Criteria: Case Ascertainment [Cancer Surveillance System (CSS)/Washington State Cancer Registry (WSCR)]:

  • Signed informed consent form providing agreement for germline genetic and molecular testing, use release of health and research information; and
  • Male aged 35 to 89 years; and
  • Diagnosis of prostate cancer; and
  • Resident of Washington state at diagnosis; and
  • Willing to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history; and
  • Willing and able to provide a saliva sample; and
  • United States (U.S.) mailing address.

Inclusion Criteria: Case Ascertainment [UW Medical Center (UWMC)/UW Harborview Medical Center (UWHMC)]:

  • Signed informed consent form providing agreement for germline genetic and molecular testing, use release of health and research information; and
  • Male aged 35 to 89 years; and
  • Diagnosis of prostate cancer; and
  • Self-identifies as Black, African American, or African; and
  • Receiving care at UWMC or UWHMC; and
  • Willing and able to provide a saliva sample; and
  • Able to provide either a U.S. mailing address or Email address or Phone number.

Inclusion Criteria: Family Recruitment

  • Signed informed consent form providing agreement for germline genetic and molecular testing, use and release of health and research information; and
  • Males aged 35 to 89 years; and
  • Willingness to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history; and
  • Willing and able to provide a saliva sample; and
  • U.S. mailing address

Exclusion Criteria: Case Ascertainment

  • Unable to provide informed consent, e.g., decisional impairment
  • Prior bone marrow transplant
  • Currently under treatment for a hematologic malignancy
  • Study team members

Exclusion Criteria: Family Recruitment

  • Unable to provide informed consent, e.g., decisional impairment
  • Prior bone marrow transplant
  • Currently under treatment for a hematologic malignancy
  • Study team members

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Case Ascertainment
Men with prostate cancer
Other: Laboratory Biomarker Analysis
Correlative Studies
Behavioral: Questionnaire
Complete questionnaire
Other Names:
  • Questionnaires
Procedure: Biospecimen Collection
Provide saliva samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Diagnostic test: Genetic Testing
Undergo genetic testing
Other Names:
  • Genetic Examination
  • Genetic Test
  • Genetic Analysis
Other: Genetic Counseling
Undergo counseling
Family Recruitment
Male relatives of men with prostate cancer
Other: Laboratory Biomarker Analysis
Correlative Studies
Behavioral: Questionnaire
Complete questionnaire
Other Names:
  • Questionnaires
Procedure: Biospecimen Collection
Provide saliva samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Diagnostic test: Genetic Testing
Undergo genetic testing
Other Names:
  • Genetic Examination
  • Genetic Test
  • Genetic Analysis
Other: Genetic Counseling
Undergo counseling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations
Time Frame: From the start of study through death (up to 20 years)
Identification to be determined through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in prostate cancer.
From the start of study through death (up to 20 years)
Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PC
Time Frame: From the start of study through death (up to 20 years)
Predictors to be identified by analyzing information provided by participants on their health history and potentially further testing or chart review on participants who consent to future contact.
From the start of study through death (up to 20 years)
Utility and feasibility of cascade genetic testing through use of family history of men with PC identified to have gDRG mutations
Time Frame: From the start of study through death (up to 20 years)
To be determined by collection of information about participants' family history and subsequent analysis of cascade genetic testing outcomes.
From the start of study through death (up to 20 years)
Identification of a cohort of men with gDRG mutations without PC
Time Frame: From the start of study through death (up to 20 years)
Identification to be determined through family history of men with PC identified through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in prostate cancer.
From the start of study through death (up to 20 years)
Effectiveness of a germline genetic testing education video: Number of participants who participate in genetic testing after watching germline genetic testing video
Time Frame: Up to 6 months
Will determine whether patients are more likely to participate in germline genetic testing after viewing an education video about prostate cancer genetic testing.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fred Hutchinson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather H Cheng, Fred Hutch/University of Washington Cancer Consortium
  • Principal Investigator: Daniel W Lin, Fred Hutch/University of Washington Cancer Consortium
  • Principal Investigator: Colin C Pritchard, Fred Hutch/University of Washington Cancer Consortium
  • Principal Investigator: Burcu Darst, Fred Hutch/University of Washington Cancer Consortium

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RG1004177
  • P50CA097186 (U.S. NIH Grant/Contract)
  • NCI-2020-00933 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 8754 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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