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New study tests if MRI-Guided biopsy spots aggressive prostate cancer better than standard method

NCT ID NCT03234556

Diagnosis Sponsor: University of Southern California 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial compares two biopsy methods for diagnosing prostate cancer in African American and white men with elevated PSA. One group gets a standard 12-core random biopsy, the other gets an MRI-guided fusion biopsy. The goal is to see which method more accurately detects clinically significant prostate cancer (Gleason score 7 or higher). The study involves 288 participants and is not recruiting new patients.

What this could mean

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

What this could lead to
If successful, this could show that MRI-guided biopsy is more accurate than standard biopsy for finding aggressive prostate cancer, potentially reducing unnecessary biopsies.
What could go wrong
This is a phase II trial with 288 participants, so results may not apply to all men. The study only includes African American and white men, limiting generalizability.

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

288 people

The number who actually took part.

Started

Sep 2017

Expected to finish

May 2028

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

40 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: * Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information * Note: HIPAA authorization may be included in the informed consent or obtained separately * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 within 3 months (93 days) prior to being registered for protocol * African-American or white men (Hispanic or non-Hispanic) * Prostate biopsy-naive or a single negative biopsy * Having elevated prostate specific antigen (PSA) (\> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE) * Ability to understand the willingness to sign a written informed consent * Patients must be willing to undergo a radiologic imaging before and after biopsy of the prostate * Patients must be willing to undergo a biopsy of the prostate Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer * Patients receiving any other investigational agents * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients with active inflammatory bowel disease * Patients who are unable to undergo MRI * Patients who had any surgery of the prostate including TURP (transurethral resection of the prostate) * Patients who had \> 1 prior prostate biopsy

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

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

Elevated PSA Health status unknown

Contacts and locations

Locations

  • Henry Ford Hospital Vattikuti Urology Institute

    Detroit, Michigan, 48202, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

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