256 Participants Needed

Education for NGS Testing in Prostate Cancer

CM
MK
Overseen ByMaddie Klugman
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase the use of next-generation sequencing (NGS) tests for patients with metastatic prostate cancer at Johns Hopkins. The researchers are testing whether educating doctors and patients can boost the rates of these important genetic tests. The trial includes two groups: one receives educational materials immediately after their first visit, and the other at the end of the study. Men with metastatic prostate cancer who are new patients at Johns Hopkins Medical Oncology in 2025 or 2026 might be a good fit, unless they have already undergone NGS testing. As an unphased trial, this study offers patients the opportunity to contribute to research that could enhance personalized cancer care through education.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this education protocol is safe for patients with metastatic prostate cancer?

Research has shown that educational programs, like the one in this trial, are generally safe. This study focuses on teaching both doctors and patients about a test called next-generation sequencing (NGS) for prostate cancer. Doctors receive emails about their frequency of using this test, while patients receive handouts or emails explaining NGS testing.

These educational activities carry no known physical risks. They aim to enhance understanding and decision-making. Similar educational programs have reported no negative effects. The goal is to share information so doctors and patients can make informed choices about NGS testing.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve prostate cancer care by educating both doctors and patients about Next-Generation Sequencing (NGS) testing. Unlike standard treatments that focus solely on medical interventions, this approach nudges physicians to consider genetic testing through informative emails and provides patients with accessible educational materials. This dual strategy could lead to more personalized treatment plans, ensuring that patients receive the most effective therapies based on their genetic profiles. By increasing awareness and knowledge, this trial could bridge the gap between cutting-edge science and everyday clinical practice, potentially leading to better outcomes for patients.

What evidence suggests that this education method is effective for improving NGS testing rates in prostate cancer?

Research shows that advanced genetic testing, known as next-generation sequencing (NGS), can improve outcomes for prostate cancer patients. Studies have found that using NGS to guide treatment decisions leads to better results. For example, one study discovered that patients lived longer when NGS guided their treatment choices. Another study emphasized that NGS testing provides crucial information that enhances patient care. This trial will explore two approaches: one arm will provide provider nudge and patient education at enrollment, while the other arm will offer provider component and patient education at the study's end. By increasing NGS testing through education, both patients and doctors could benefit from improved treatment outcomes.12678

Who Is on the Research Team?

CM

Catherine Marshall, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for men diagnosed with metastatic prostate cancer who are new patients at Johns Hopkins Medical Oncology between January 1, 2025 and December 31, 2026.

Inclusion Criteria

I will have my first visit with Johns Hopkins Medical Oncology between 2025 and 2026.
I am a man diagnosed with prostate cancer that has spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Education

Provider nudge and patient education at time of enrollment, including a 'nudge' email to physicians and educational material to patients

4 weeks
1 visit (in-person or virtual)

Follow-up

Participants are monitored for NGS testing rates and receive additional educational material at the end of the study

8 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Provider-level and patient education

Trial Overview

The study aims to increase next-generation sequencing (NGS) testing rates by addressing provider-level and patient-level barriers through education at the end of the study.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Provider nudge and patient education at time of enrollmentExperimental Treatment1 Intervention
Group II: Provider component and patient education at end of studyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

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Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

Usefulness and real-world outcomes of next generation ... - PMC

NGS testing showed an association with improved outcomes in our series when it was performed for either making a therapeutic decision in ...

Barriers to and clinical outcomes with next-generation ...

In this study, we determined the NGS testing rate in M1 prostate cancer at a single academic center and assessed social and clinical features by ...

Physician- and Patient-based Barriers to NGS Testing

The goal of this study is to improve next-generation sequencing (NGS) testing rates at Johns Hopkins in patients with metastatic prostate cancer. Investigators ...

Value of next generation sequencing (NGS) testing in ...

Overall survival was estimated to increase by 0.6 months in prostate cancer, 0.9 months in breast cancer, 3.9 months in NSCLC patients, and 14.2 months in CRC (

A Review of Liquid, Tissue-Based and Combined Next- ...

Next-generation sequencing (NGS) is an invaluable testing method offering clinically significant information to improve patient outcomes.

Potential barriers to implementation of next-generation ... - PMC

The purpose of this study was to identify barriers to physicians' NGS use and preferred strategies to alleviate these barriers.

Race, Ethnicity, and Tumor Genomic Testing in Prostate ...

Tumor next-generation sequencing (NGS) has implications for treatment selection, prognostication, and counseling of patients and is recommended ...

Using Next-Generation Sequencing to Target Tumor ...

Using Next-Generation Sequencing to Target Tumor Genomics in Metastatic Prostate Cancer. Actionability of tumor DNA data remains limited.