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Physician- and Patient-based Barriers to NGS Testing

A Clinical Trial to Address Physician- and Patient-based Barriers to NGS Testing

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07209176
Enrollment
256
Registered
2025-10-06
Start date
2026-01-06
Completion date
2027-09-06
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Prostate Cancer

Keywords

metastatic prostate cancer, next-generation sequencing

Brief summary

The goal of this study is to improve next-generation sequencing (NGS) testing rates at Johns Hopkins in patients with metastatic prostate cancer. Investigators believe by targeting two barriers, provider-level and patient-level, will improve the testing rate of NGS at Johns Hopkins.

Detailed description

Next-generation sequencing is recommended by national guidelines in metastatic prostate cancer to inform prognosis, treatment decisions, and eligibility for clinical trials. However, rates are low nationally and around 50-60% at Johns Hopkins. Analysis found that older patients and patients who are not married are less likely to have testing performed. The goals and objectives of this proposed clinical trial are to improve NGS testing rates at Johns Hopkins using a multidisciplinary approach to improve the care of patients living with metastatic prostate cancer and reduce disparities. The hypothesis is that this initiative, which targets two barriers (provider-level and patient-level), will lead to higher rates of NGS ordering at Johns Hopkins.

Interventions

OTHERProvider-level and patient education at end of study

The provider level component will involve an email to each of the genitourinary medical oncologists at Johns Hopkins with their NGS testing rate from preliminary data and compare this rate to the mean. The initial email will also include the 2025 ASCO guideline recommending somatic testing in virtually all metastatic prostate cancer patients. Providers who do not have baseline NGS testing rates available will also be emailed. Providers will subsequently be emailed their updated NGS testing rate at the conclusion of the study period. Patients will also receive a one-page patient educational material (via email, or mail if no email on file) on advanced prostate cancer that includes education on somatic NGS testing at the end of the study period.

OTHERProvider-level and patient-level

In addition to the provider component, patients will also receive a one-page patient educational material (via email, or mail if no email on file) on advanced prostate cancer that includes education on somatic NGS testing. The email will be sent by the MyChart Recruitment Innovation team. Those without email on file will have the same message and attachment sent via mail by our study coordinator.

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead SponsorOTHER
Pfizer
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* men diagnosed with metastatic prostate cancer * seen by Johns Hopkins Medical Oncology as a new patient visit between January 1, 2025 and December 31, 2026

Exclusion criteria

\- Patients who have already had NGS testing performed.

Design outcomes

Primary

MeasureTime frame
Rate of Next-Generation Sequencing (NGS) testing by arm1 year

Secondary

MeasureTime frame
Percentage of patients with sociodemographic and clinical characteristics who have had NGS testing compared to those without NGS testing during the study period.1 year

Countries

United States

Contacts

CONTACTCatherine Marshall, MD
chm@jhmi.edu410-955-0231
CONTACTMaddie Klugman
mklugma2@jh.edu410-955-8893
PRINCIPAL_INVESTIGATORCatherine Marshall, MD

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026