Targeting gut bacteria to improve prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate whether the combination of dexamethasone with or without metronidazole can restore sensitivity to abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC). The research focuses on the gut microbiome's role in producing androgens that may contribute to resistance against abiraterone therapy. Participants will receive these medications while undergoing monitoring for prostate-specific antigen (PSA) levels and other health indicators. The study seeks to understand the relationship between gut bacteria and treatment resistance in prostate cancer.

Why it matters

Who can join: the full rules

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 it's running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Catherine Handy Marshall, M.D. — Johns Hopkins University
• Study coordinator: Donna Bieg, RN
• Email: dieg2@jhmi.edu
• Phone: 410-502-7635

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• PSMA PET-Staged Progression-Directed Radiotherapy for Limited Prostate Cancer Progression

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• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

  This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.