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OpenTrials
Completed

NCT Number: NCT05447637

PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients

This registry is for men who have prostate cancer and have had multigene panel hereditary testing. The registry will gather data on genetic testing results and how that information may change physician treatment or follow up recommendations. It will also gather data on the patient's experience with genetic testing, through a post-test survey to be completed 60-90days after results have been received and discussed with their provider.

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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–90 year

Sex eligibility

Male

Study type

Observational

Primary location

Genesis Healthcare Partners, San Diego, California, United States

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About this study

This registry will enroll men with prostate cancer who have done multi-gene testing for their cancer. Patients will be enrolled into two cohorts, one for individuals who meet current NCCN testing guidelines, and one for individuals who do not meet current NCCN guidelines.

The main goal of this Registry is to assess whether nationally developed guidelines used to select patients for hereditary testing are adequate to identify all patients with prostate cancer who may benefit from testing. Patients will completed a post-test survey regarding their testing experience and clinicians will be asked to provide additional medical records review information via the Clinician Report Form.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men ages 18-90 who have been prescribed genetic testing as part of their clinical care
  • Have prostate cancer at any stage, either actively under treatment or being followed who either: 1. meet NCCN criteria for testing or 2. do not meet NCCN criteria for testing
  • Patients who are naive to clinical genetic testing for BRCA1/BRCA2 (single gene panel testing)

Exclusion criteria

  • Mental or cognitive impairment that interferes with ability to provide informed consent

Treatment and study plan

Invitae multi-cancer gene panel

Diagnostic Test

Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.

Primary outcomes

  1. Diagnostic yield of pathogenic and likely pathogenic genes in the patient population

    Time frame: to be assessed at baseline only

    Identify the diagnostic yield of pathogenic/likely pathogenic variants in known cancer syndrome genes in patients with prostate cancer, using the Invitae 84 gene multi-cancer panel. These rates will be compared between the two cohorts.

Secondary outcomes

  1. Evaluate the sensitivity of current NCCN criteria for germline genetic testing for identifying prostate cancer patients that have pathogenic/likely pathogenic variants

    Time frame: at baseline only

    Compare rates of pathogenic / likely pathogenic variants found in both cohorts after testing using the Invitae 84 gene multi cancer panel.

  2. Evaluate the impact of genetic test results on clinical management decisions

    Time frame: 60-90 days post test results received.

    Post-Test surveys for patients and the clinician report form will assess whether changes to clinical management were made as a result of the test results.

Sponsors and collaborators

Lead sponsor

Invitae Corporation

Industry

Registry information

Official study title

A Multi-center Prospective Observational Study of Community Urology Practices Applying Germline Genetic Testing for Prostate Cancer Patients (PROCLAIM)

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 7, 2022
Registry last updated
Jul 7, 2022

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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