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Smarter prostate cancer detection: new combo test aims to reduce unnecessary biopsies

NCT ID NCT04240327

Diagnosis Sponsor: University of Miami 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether combining a special MRI analysis (called Habitat Risk Score) with blood and urine tests can more accurately rule out aggressive prostate cancer than the standard MRI reading. About 289 men with elevated PSA or abnormal exams will be enrolled. The goal is to avoid unnecessary biopsies while catching dangerous cancers.

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

289 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Jun 2027

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.

Who is studied

Study participants will be targeted for enrollment from a consecutive cohort of men who are referred to the University of Miami for prostate cancer evaluation and management, which includes internal and external physician referrals, most often due to an increased PSA, and/or abnormal digital rectal exam (DRE).

Ages

40 to 85 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Male participant, aged 40-85 years. 2. In good general health as evidenced by medical history. 3. Referred for a biopsy of the prostate for evaluation of prostate cancer due to elevated or increasing prostate-specific antigen (PSA) or an abnormal digital rectal exam (DRE). 4. Participant must agree to forego testosterone supplementation during the duration of the study due to unknown impacts on prostate cancer biomarkers. Exclusion Criteria: 1. Previous or current history of prostate cancer or treatment for prostate cancer. 2. Previous history of pelvic radiation. 3. Known allergic reactions to MRI contrast or inability to undergo MRI due to renal toxicity. 4. Inability to undergo blood draw or biopsy of the prostate as per protocol. 5. Prior MRI guided biopsy of the prostate for prostate cancer evaluation. 6. Previous prostate biopsy or prostate procedure within 6 months of enrollment within the trial. 7. Standard contraindications to MRI, such as allergies to contrast die, renal toxicity, ferromagnetic metal in body/eye, pacemaker, defibrillator, other mechanical device, or extreme claustrophobia (medication with anti-anxiety agents, such as Ativan, may be attempted) will prevent eligibility and will be applied for all protocol-related MRIs. 8. Patients with impaired decision-making capacity.

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Conditions

The condition(s) this trial relates to.

pleomorphic adenoma prostate cancer

As listed by the trial registrant

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

Elevated PSA Prostate cancer PSA

Contacts and locations

Locations

  • University of Miami

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.