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Trial Targeting Gut Bacteria to Reverse Abiraterone Resistance in Metastatic Prostate Cancer

This study is for men with metastatic prostate cancer (cancer that has spread) whose abiraterone (a hormone therapy) treatment is no longer working. Researchers are testing if adding dexamethasone (a steroid) or dexamethasone plus metronidazole (an antibiotic) to your abiraterone treatment can make abiraterone effective again. The study aims to see if changing gut bacteria, which might be producing hormones that make the cancer resistant, can help. To join, you must be a man aged 18 or older with prostate cancer that has spread, a PSA (prostate-specific antigen) level of 2.0 ng/mL or higher, and have experienced cancer progression while on abiraterone and prednisone for at least 12 weeks. The study will measure success by looking at how many participants have a 30% or more drop in their PSA levels after 24 weeks. The current recruitment status is unclear.

Study design
This study plans to enroll 58 participants. It is an interventional study, meaning participants will receive specific treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 24 weeks, indicating follow-up for at least that duration.

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NCT06616597

Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~58 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:Abiraterone acetateDexamethasoneMetronidazole

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with PSA30 response
Measured over 24 weeks

Conditions

Prostate Cancer (Adenocarcinoma)
Metastatic Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Catherine Handy Marshall, M.D. · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Donna Bieg, RN
[email protected]
410-502-7635
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants with PSA30 response24 weeks

    Number of participants with castration resistant prostate cancer who have a ≥ 30% decline in PSA from baseline until 24 weeks.