Prostate CarcinomaGIFTSNCT04254133
Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
An observational study of Prostate Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 89 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Questionnaire, Biospecimen Collection and Genetic Testing
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 1,360 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2018to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 89 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients living in Washington State with a new diagnosis of prostate cancer and first degree relatives of patients with prostate cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Questionnaire, Biospecimen Collection, Genetic Testing, Genetic Counseling, Laboratory Biomarker Analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Questionnaires
Complete questionnaire
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Provide saliva samples
Genetic TestingDiagnostic test
Also called Genetic Analysis, Genetic Examination, Genetic Test
Undergo genetic testing
Genetic CounselingOther
Undergo counseling
Laboratory Biomarker AnalysisOther
Correlative Studies
| Study group | Role | What they receive |
|---|---|---|
| Case Ascertainment | Men with prostate cancer Receives: 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 Receives: Behavioral: Questionnaire; Procedure: Biospecimen Collection; Diagnostic Test: Genetic Testing; Other: Genetic Counseling; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Will determine whether patients are more likely to participate in germline genetic testing after viewing an education video about prostate cancer genetic testing.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 Nov 2018
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Burcu Darst, Principal investigator, Fred Hutch/University of Washington Cancer ConsortiumHeather H Cheng, Principal investigator, Fred Hutch/University of Washington Cancer ConsortiumDaniel W Lin, Principal investigator, Fred Hutch/University of Washington Cancer ConsortiumColin C Pritchard, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254133
- Sponsor's protocol ID
- RG1004177
- Other IDs
- P50CA097186, NCI-2020-00933, 8754
- Acronym
- GIFTS
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer
- ClinicalTrials.gov ID
- NCT04254133
- Acronym / sponsor ID
- GIFTS / RG1004177
- Conditions
- Prostate Carcinoma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,360 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Ascertainment | – | Behavioral: Questionnaire, Procedure: Biospecimen Collection, Diagnostic Test: Genetic Testing, Other: Genetic Counseling, Other: Laboratory Biomarker AnalysisMen with prostate cancer |
| Family Recruitment | – | Behavioral: Questionnaire, Procedure: Biospecimen Collection, Diagnostic Test: Genetic Testing, Other: Genetic Counseling, Other: Laboratory Biomarker AnalysisMale relatives of men with prostate cancer |
Who may qualify
- Ages
- 35 to 89 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients living in Washington State with a new diagnosis of prostate cancer and first degree relatives of patients with prostate cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: QuestionnairesComplete questionnaire | Behavioural | Case Ascertainment, Family Recruitment |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionProvide saliva samples | Procedure or surgery | Case Ascertainment, Family Recruitment |
| Genetic TestingAlso: Genetic Analysis, Genetic Examination, Genetic TestUndergo genetic testing | Diagnostic test | Case Ascertainment, Family Recruitment |
| Genetic CounselingUndergo counseling | Other | Case Ascertainment, Family Recruitment |
| Laboratory Biomarker AnalysisCorrelative Studies | Other | Case Ascertainment, Family Recruitment |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.