Prostate CancerIMPRINTNCT05470036
Improving Germline Testing in At-Risk Patients With Prostate Cancer
A study testing Educational intervention. in people with Prostate Cancer, run by University of California, San Diego at 1 site in United States.
Trial summary
A quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Educational intervention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2022to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men, age greater than or equal to 18 years of age.
- Diagnosis of prostate cancer of any histology.
- Must meet NCCN guidelines for germline testing
Who cannot join
- Have had prior germline testing.
- Have somatic genetic testing that is positive for a possible germline variant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92037
About this study
Official title: IMPRINT: A Pilot Study to Improve Germline Testing in At-Risk Patients With Prostate Cancer
A quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session.
Read the detailed description
This is a prospective single arm quality improvement initiative for the use of a standardized educational intervention on germline testing in prostate cancer to improve the rates of germline genetic testing among patients recommended for testing. Patients who consent to the study will undergo a one-on-one education session regarding the rationale and the benefits/risks of germline testing. Following the educational session, if a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay.
- Conditions
- Prostate Cancer
- Being tested
- Educational intervention.
- Keywords
- Prostate cancer, Germline testing, Education, Video
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention.Behavioural
Educational intervention with trained educator on overview, rationale, implications, and risks and benefits of germline testing in prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention | Other | In-clinic or virtual educational session on germline testing in prostate cancer with a trained educator. Receives: Behavioral: Educational intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention.
Germline genetic testing among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.
Measured: Within 1 year
Secondary outcomes (4)
Patient Baseline Knowledge of Germline Testing
Assessment via baseline knowledge questionnaire.
Survey Title: Patient Survey on Germline Testing in Prostate Cancer
Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge)
Higher score = higher knowledge
Measured: Baseline
Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing
Assessment via post intervention questionnaire.
Survey Title: Patient Post-Education Patient Survey
Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge)
Higher score = higher knowledge
Measured: Within 18 months
Number of Participants With Pathogenic Germline Mutations
Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance.
Measured: within 18 months
Patient Knowledge of Germline Testing After the Educational Intervention.
Assessment via post intervention knowledge questionnaire.
Survey Title: Patient Survey on Germline Testing in Prostate Cancer
Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge)
Higher score = higher knowledge
Measured: within 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start27 Sep 2022
- Primary completion1 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Mckay, University of California, San Diego
- Investigators
- Rana McKay, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470036
- Sponsor's protocol ID
- 20-0551
- Acronym
- IMPRINT
- Status last verified
- Dec 2025
- First submitted
- 17 Jul 2022
- Last updated
- 16 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPRINT: A Pilot Study to Improve Germline Testing in At-Risk Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT05470036
- Acronym / sponsor ID
- IMPRINT / 20-0551
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Germline testing, Education, Video
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Posted 16 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session.
Detailed description
This is a prospective single arm quality improvement initiative for the use of a standardized educational intervention on germline testing in prostate cancer to improve the rates of germline genetic testing among patients recommended for testing. Patients who consent to the study will undergo a one-on-one education session regarding the rationale and the benefits/risks of germline testing. Following the educational session, if a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Other | Behavioral: Educational intervention.In-clinic or virtual educational session on germline testing in prostate cancer with a trained educator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men, age greater than or equal to 18 years of age.
- Diagnosis of prostate cancer of any histology.
- Must meet NCCN guidelines for germline testing
Key exclusion criteria (2 listed)
- Have had prior germline testing.
- Have somatic genetic testing that is positive for a possible germline variant.
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 |
|---|---|---|
| Educational intervention.Educational intervention with trained educator on overview, rationale, implications, and risks and benefits of germline testing in prostate cancer. | Behavioural | Educational intervention |
Primary outcome
Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention.
Time frame: Within 1 year
Germline genetic testing among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.
4 secondary outcomes
Patient Baseline Knowledge of Germline Testing
Time frame: Baseline
Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing
Time frame: Within 18 months
Number of Participants With Pathogenic Germline Mutations
Time frame: within 18 months
Patient Knowledge of Germline Testing After the Educational Intervention.
Time frame: within 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Rana McKay, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention. in people with Prostate Cancer, run by University of California, San Diego 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 16 Jan 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?
Yes. Results are posted in the registry (first posted 16 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention. (time frame: Within 1 year). 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 16 Jan 2026.