Metastatic Prostate CancerNCT07209176
Physician- and Patient-based Barriers to NGS Testing
A study testing Provider-level and patient education at end of study and Provider-level and patient-level in people with Metastatic Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- Provider-level and patient education at end of study and Provider-level and patient-level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 6 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 diagnosed with metastatic prostate cancer
- seen by Johns Hopkins Medical Oncology as a new patient visit between January 1, 2025 and December 31, 2026
Who cannot join
- Patients who have already had NGS testing performed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21205
Cathy Marshall, MD, 410-955-0231, chm@jhmi.edu
About this study
Official title: A Clinical Trial to Address 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 believe by targeting two barriers, provider-level and patient-level, will improve the testing rate of NGS at Johns Hopkins.
Read the 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.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- Provider-level and patient education at end of study, Provider-level and patient-level
- Keywords
- metastatic prostate cancer, next-generation sequencing
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider-level and patient education at end of studyOther
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.
Provider-level and patient-levelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Provider nudge and patient education at time of enrollment | Experimental | The provider level component (implemented for all patients) will be a "nudge" to physicians to order testing via a single email documenting their NGS testing rate relative to the Johns Hopkins top performer and, for those not in the top 20%, a link to the most recent American Society of Clinical Oncology (ASCO) guidelines recommending testing. In addition, there will be a patient component that is a one-page handout of educational material about NGS testing to be sent after their initial visit via email or mail. Receives: Other: Provider-level and patient-level |
| Provider component and patient education at end of study | Experimental | The provider level component (implemented for all patients) will be a "nudge" to physicians to order testing via a single email documenting their NGS testing rate relative to the Johns Hopkins top performer and, for those not in the top 20%, a link to the most recent ASCO guidelines recommending testing. The patient educational material will be provided by email or mail (if no email on file) to those who randomized to this arm. Receives: Other: Provider-level and patient education at end of study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Next-Generation Sequencing (NGS) testing by arm
Measured: 1 year
Secondary outcomes (1)
Percentage of patients with sociodemographic and clinical characteristics who have had NGS testing compared to those without NGS testing during the study period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start6 Jan 2026
- Primary completion6 Sep 2027 (estimated)
- Study completion6 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Catherine Marshall, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209176
- Sponsor's protocol ID
- IRB00505965
- Other IDs
- IRB00505965
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Address Physician- and Patient-based Barriers to NGS Testing
- ClinicalTrials.gov ID
- NCT07209176
- Acronym / sponsor ID
- IRB00505965
- Conditions
- Metastatic Prostate Cancer
- Keywords
- metastatic prostate cancer, next-generation sequencing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 6 Sep 2027 (estimated)
- Study completion
- 6 Sep 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider nudge and patient education at time of enrollment | Experimental | Other: Provider-level and patient-levelThe provider level component (implemented for all patients) will be a "nudge" to physicians to order testing via a single email documenting their NGS testing rate relative to the Johns Hopkins top performer and, for those not in the top 20%, a link to the most recent American Society of Clinical Oncology (ASCO) guidelines recommending testing. In addition, there will be a patient component that is a one-page handout of educational material about NGS testing to be sent after their initial visit via email or mail. |
| Provider component and patient education at end of study | Experimental | Other: Provider-level and patient education at end of studyThe provider level component (implemented for all patients) will be a "nudge" to physicians to order testing via a single email documenting their NGS testing rate relative to the Johns Hopkins top performer and, for those not in the top 20%, a link to the most recent ASCO guidelines recommending testing. The patient educational material will be provided by email or mail (if no email on file) to those who randomized to this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have already had NGS testing performed.
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 |
|---|---|---|
| Provider-level and patient education at end of studyThe 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. | Other | Provider component and patient education at end of study |
| Provider-level and patient-levelIn 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. | Other | Provider nudge and patient education at time of enrollment |
Primary outcome
Rate of Next-Generation Sequencing (NGS) testing by arm
Time frame: 1 year
1 secondary outcome
Percentage of patients with sociodemographic and clinical characteristics who have had NGS testing compared to those without NGS testing during the study period.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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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.
Catherine Marshall, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider-level and patient education at end of study and Provider-level and patient-level in people with Metastatic Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Marshall, MD (410-955-0231, chm@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Next-Generation Sequencing (NGS) testing by arm (time frame: 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 3 Feb 2026.