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Gut bacteria may hold key to reversing prostate cancer drug resistance

NCT ID NCT06616597

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether adding dexamethasone or metronidazole to standard therapy can restore sensitivity to abiraterone in men with metastatic prostate cancer that has stopped responding. About 58 men whose cancer progressed on abiraterone will receive either dexamethasone or dexamethasone plus metronidazole. The goal is to see if these additions lower PSA levels and delay further progression.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 58 people

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

Started

Feb 2025

Expected to finish

Mar 2032

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: * Males aged 18 years of age and above. * Prostate adenocarcinoma * Absolute PSA ≥ 2.0 ng/mL at screening. * PSA (+/- radiographic) progression after having been on abiraterone and prednisone for at least 12 weeks. * Must be maintained on a GnRH analogue or have undergone orchiectomy. * Participants must have a life expectancy ≥ 6 months * Ability to swallow study medication tablets * Willing to abstain from alcohol during and for 14 days after treatment with metronidazole * Willing and able to collect urine and stool samples per protocol Exclusion Criteria: * Active infection or other medical condition that would make dexamethasone use contraindicated * Any chronic medical condition requiring a higher systemic dose of corticosteroid * Pathological finding consistent with small cell carcinoma of the prostate * Has imminent or established spinal cord compression based on clinical findings and/or MRI. * Chronic liver disease with Child-Pugh class C cirrhosis (see calculator in protocol) * Bilirubin \>3x ULN or AST and ALT \>5x ULN * Congenital prolonged QTc syndrome or QTc \> 500 msec (non-paced rhythm) * History of pituitary or adrenal dysfunction * Uncontrolled diabetes (Hemoglobin A1c \> 10%) or increasing doses of insulin within the past 4 weeks due to poorly controlled glucoses. * Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 30 days of Cycle 1 Day 1 or currently enrolled in an investigational drug study * Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including, but not limited to: * Any uncontrolled major infection. * Crohn's disease or ulcerative colitis. * Known or suspected toxic megacolon and/or known small bowel ileus. * Known allergy to any of the compounds under investigation. * On antibacterial therapy within 30 days prior to administration of study treatment. * Any condition or situation which, in the opinion of the investigator, would put the subject at risk, or interfere with the subject's participation in this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    RECRUITING

    Baltimore, Maryland, 21231, United States

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