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Completed

NCT Number: NCT05470036

Improving 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • Have had prior germline testing.
  • Have somatic genetic testing that is positive for a possible germline variant.

Treatment and study plan

Educational intervention.

Behavioral

Educational intervention with trained educator on overview, rationale, implications, and risks and benefits of germline testing in prostate cancer.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient Baseline Knowledge of Germline Testing

    Time frame: Baseline

    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

  2. Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing

    Time frame: Within 18 months

    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

  3. Number of Participants With Pathogenic Germline Mutations

    Time frame: within 18 months

    Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance.

  4. Patient Knowledge of Germline Testing After the Educational Intervention.

    Time frame: within 18 months

    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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

IMPRINT: A Pilot Study to Improve Germline Testing in At-Risk Patients With Prostate Cancer

Acronym: IMPRINT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2022
Registry last updated
Jan 16, 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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