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Can a genetic test and MRI team up to improve prostate cancer treatment choices?

NCT ID NCT04541030

Knowledge-focused Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 13 times

Summary

This study looks at whether combining a genetic test called the Genomic Prostate Score (GPS) with MRI scans can help doctors better choose men with prostate cancer for focal therapy, which treats only the cancerous part of the prostate. Researchers will analyze data and tissue samples from 241 men who previously had prostate surgery. The goal is to see if the GPS score, along with MRI results, can predict which cancers are more aggressive and need broader treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oncotype DX Genomic Prostate Score (GPS) test
What this could lead to
If successful, this could help doctors more accurately choose which men with prostate cancer are good candidates for focal therapy, potentially reducing side effects from more aggressive treatments.
What could go wrong
This is a retrospective study using existing data, not a new treatment trial. The GPS test is already in use, so the main question is how well it works with MRI, not a breakthrough discovery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

241 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Samples from male patients with NCCN low or intermediate risk disease managed with radical prostatectomy (multiparametric MRI (mpMRI) performed within 6 months prior to the prostatectomy indicating localized, organ confined disease and adequate diagnostic biopsy tissue specimen).

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: * Samples and images from men \> =18 with NCCN very low, low, or intermediate risk prostate cancer with tumor tissue that meet the pathologic tissue requirements of the Oncotype DX Genomic Prostate Score assay * Biopsy Gleason Score 7 or lower within 6 months preceding radical prostatectomy * 3Tesla MRI with/without coil performed within 6 months preceding diagnostic biopsy * Availability of diagnostic biopsy EXCLUSION CRITERIA: * Any active therapy received for prostate cancer (e.g., hormonal treatment, radiation, chemotherapy, biologic agents, surgery) prior to radical prostatectomy. 5 alpha reductase inhibitor treatment will not be considered to be hormonal treatment for this definition * Men with NCCN high risk or very high-risk prostate cancer * Biopsy Gleason 8 * No biopsy tissue available * Missing surgical pathology whole mount, or unwilling to send surgical pathology whole mount to NCI for review * Missing diagnostic PSA * Missing clinical T stage * Known lymph node positive or metastatic disease at time of diagnosis * Missing MRI 6 months before diagnostic biopsy

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • National Cancer Institute (NCI)

    Bethesda, Maryland, 20892, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

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