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

NCT04254133 | Enrolling By Invitation

• 4 other identifiers: RG1004177P50CA097186NCI-2020-009338754
• Study Type: observational
• Target: 1,360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (5)

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

  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

  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

  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

  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

  Up to 6 months

Study Arms (2)

Case Ascertainment

Men with prostate cancer

Behavioral: Questionnaire; Procedure: Biospecimen Collection; Diagnostic Test: Genetic Testing; Other: Genetic Counseling; Other: Laboratory Biomarker Analysis

Family Recruitment

Male relatives of men with prostate cancer

Behavioral: Questionnaire; Procedure: Biospecimen Collection; Diagnostic Test: Genetic Testing; Other: Genetic Counseling; Other: Laboratory Biomarker Analysis

Interventions

Questionnaire BEHAVIORAL

Complete questionnaire

Also known as: Questionnaires

Case Ascertainment; Family Recruitment

Biospecimen Collection PROCEDURE

Provide saliva samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Case Ascertainment; Family Recruitment

Genetic Testing DIAGNOSTIC_TEST

Undergo genetic testing

Also known as: Genetic Analysis, Genetic Examination, Genetic Test

Case Ascertainment; Family Recruitment

Genetic Counseling OTHER

Undergo counseling

Case Ascertainment; Family Recruitment

Laboratory Biomarker Analysis OTHER

Correlative Studies

Case Ascertainment; Family Recruitment

Eligibility Criteria

• Age: 35 Years - 89 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires; Specimen Handling; Genetic Testing; Genetic Counseling

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Burcu Darst

  Fred Hutch/University of Washington Cancer Consortium

  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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: November 30, 2018
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)