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GIFTS Study: Genetic Information for Prostate Cancer Treatment and Screening

This observational study, called GIFTS, is looking at how inherited changes (mutations) in genes like BRCA1, BRCA2, and ATM affect prostate cancer. Researchers want to understand how common these mutations are in men with prostate cancer and if they can help find better ways to treat the disease. You may be able to join if you are a man between 35 and 89 years old, have been diagnosed with prostate cancer, and live in Washington state. The study aims to identify men with these genetic changes and understand what predicts who carries them. It also looks at how useful genetic testing is for family members. The study is currently unclear on its recruitment status and plans to enroll 1360 participants.

Study design
This is an observational study involving 1360 men with prostate cancer. It is not a randomized trial.
What's involved
You will complete a questionnaire at the start and provide a saliva sample for genetic testing. You may also receive genetic counseling and educational materials.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of the study through death, for up to 20 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04254133

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

Enrolling by Invitation
Not specifiedAges 35–89Observational
Fred Hutchinson Cancer Center
~1,360 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:QuestionnaireBiospecimen CollectionGenetic TestingGenetic CounselingLaboratory Biomarker Analysis

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations
Measured over From the start of study through death (up to 20 years)
+4 more outcomes measured

Conditions

Prostate Carcinoma

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Burcu Darst · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
  • Heather H Cheng · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
  • Daniel W Lin · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
  • Colin C Pritchard · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
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

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

What this trial measures

  • Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutationsFrom 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.

  • Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PCFrom 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.

  • Utility and feasibility of cascade genetic testing through use of family history of men with PC identified to have gDRG mutationsFrom 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.

  • Identification of a cohort of men with gDRG mutations without PCFrom 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.

  • Effectiveness of a germline genetic testing education video: Number of participants who participate in genetic testing after watching germline genetic testing videoUp 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.