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

January 28, 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

Enrolling by invitation

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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

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
Intervention / Treatment
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

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
Up to 6 months

Collaborators and Investigators

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

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • 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)

November 30, 2018

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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