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Can MRI predict finasteride failure? new study seeks answers

NCT ID NCT04288427

Knowledge-focused Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 aims to understand why some men with an enlarged prostate (BPH) do not respond to the common drug finasteride. Researchers will follow 120 men starting finasteride, tracking their symptoms and using MRI scans and genetic tests over three years. The goal is to find ways to predict resistance early, so non-responders can try other treatments sooner.

What this could mean

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

Active substance
Finasteride
What this could lead to
If successful, this could help doctors identify non-responders to finasteride before treatment, saving time and offering alternative therapies sooner.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to a new therapy, and results may not apply to all patients.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Nov 2026

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

50 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: * Male (physiological); * Age ≥ 50; * Eligible for treatment with 5ARI therapy; * Presence of lower urinary tract symptoms secondary to BPH; * Prostate size \>40cc by digital rectal examination; * Absence of prostate nodule, tenderness or firmness; * Mildly elevated PSA's \>1.5 ng/ml and ≤ 40 ng/ml; * Undergoing clinically indicated prostate biopsy for elevated prostate-specific antigen (PSA). Exclusion Criteria: * Diagnosis of any prostatic malignancy or precancerous lesions (atypical glandular foci and prostatic intraepithelial neoplasia); * Treatment with 5ARI (Finasteride or Dutasteride) within six months of study enrollment; * Current urinary tract infection; * Previous pelvic radiation; * Previous treatment with demethylating drugs; * Diagnosis of multiple sclerosis, Alzheimer's, Parkinson's, neurological deficits in the judgment of the investigator; * Unable or unwilling to undergo MRI due to implants, claustrophobia, etc.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Lower Urinary Tract Symptoms prostate disorder urinary system disorder urinary tract obstruction

As listed by the trial registrant

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

Benign prostatic hyperplasia Lower urinary tract symptoms Prostate disease Prostate hyperplasia Prostate hypertrophy Prostate pain Urinary obstruction Urinary tract disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

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