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Enrolling by Invitation

NCT Number: NCT04254133

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

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.

Enrolling by Invitation

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Key information

Age range

35 year–89 year

Sex eligibility

Male

Study type

Observational

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Behavioral

Complete questionnaire

Other names: Questionnaires

Biospecimen Collection

Procedure

Provide saliva samples

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Genetic testing

Diagnostic Test

Undergo genetic testing

Other names: Genetic Analysis, Genetic Examination, Genetic Test

Genetic Counseling

Other

Undergo counseling

laboratory biomarker analysis

Other

Correlative Studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: GIFTS

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2020
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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