NCT06616597 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer
What this study is about
To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.
View original scientific description
To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Baltimore, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations