NCT06616597RecruitingPhase 2
Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer
Phase II Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 23 Sept 2024
- Start date
- 13 Feb 2025
- Primary completion date
- 30 Mar 2031
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Prostate cancer
- NCT number
- NCT06616597
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 58
- From 13 Feb 2025 to the primary completion date, 30 Mar 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- On antibacterial therapy within 30 days prior to administration of study treatment.
Other illness
- Active infection or other medical condition that would make dexamethasone use contraindicated
- Any chronic medical condition requiring a higher systemic dose of corticosteroid
- Chronic liver disease with Child-Pugh class C cirrhosis (see calculator in protocol)
- History of pituitary or adrenal dysfunction
- 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.
- 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.
Lab values
- Bilirubin \>3x ULN or AST and ALT \>5x ULN
- Congenital prolonged QTc syndrome or QTc \> 500 msec (non-paced rhythm)
- Uncontrolled diabetes (Hemoglobin A1c \> 10%) or increasing doses of insulin within the past 4 weeks due to poorly controlled glucoses.
Other
- Pathological finding consistent with small cell carcinoma of the prostate
- Has imminent or established spinal cord compression based on clinical findings and/or MRI.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.