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Gene test may help men with prostate cancer skip treatment safely

NCT ID NCT04396808

Disease control Sponsor: University of Michigan Rogel Cancer Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study looks at whether a special gene test can help men with low-risk prostate cancer decide to monitor their cancer instead of treating it right away. About 805 men with early-stage prostate cancer will be randomly assigned to have the gene test or not. The goal is to see if the test helps more men safely choose active surveillance (watchful waiting) without their cancer getting worse.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

805 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: * Prostate cancer patients who have undergone diagnostic prostate biopsy in the past 9 months. * Prostate biopsy tumor tissue (FFPR block) available for processing * Age 18 years or older * PSA \<20 ng/ml * Grade Group (GG) 1 cancer with \> 2 biopsy cores involved with cancer OR GG2 cancer * Ability to understand and the willingness to sign a written informed consent. A subject's legally acceptable representative may sign the consent form. Exclusion Criteria: * Clinical (on digital rectal exam) or radiographic evidence (if MRI performed) of T3 disease * Nodal or metastatic prostate cancer (if staging imaging performed) * Prior prostate cancer treatment, including prostatectomy, radiation therapy, or hormone therapy. * Prior prostate gene expression classier testing

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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

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Sherwood Medical Center

    Detroit, Michigan, 48221, United States

  • Spectrum Health Medical Group

    Grand Rapids, Michigan, 49503, United States

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Western Michigan Urological Associates

    Holland, Michigan, 49423, United States

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